Medtronic Vascular

FDA Filings

This page includes the latest FDA filings for Medtronic Vascular. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

Medtronic Vascular holds import registrations or U.S. agent authorizations in conjunction with the following organizations:

• MEDTRONIC MEXICO EG
• GERARDINE FINN
• Aine Smalley

FDA Registration(s)

• Registration Number: 3005364322
• FEI Number: 3005364322
• Name: Medtronic Vascular
• Owner & Operator: MEDTRONIC INC.
• Contact Address: 710 Medtronic Pkwy. ; Minneapolis MN 55432 US
• Official Correspondent:
  • CHRISTINE - BOES
  • x-763-5260396-x
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 3850 Brickway Blvd ; Santa Rosa, CA 95403 US
• Establishment Type: Develop Specifications But Do Not Manufacture At This Facility

• Registration Number: 1220452
• FEI Number: 1220452
• Name: MEDTRONIC VASCULAR
• Owner & Operator: MEDTRONIC INC.
• Contact Address: 710 Medtronic Pkwy. ; Minneapolis MN 55432 US
• Official Correspondent:
  • CHRISTINE - BOES
  • x-763-5260396-x
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 37A Cherry Hill Dr ; DANVERS, MA 01923 US
• Establishment Type:
  • Develop Specifications But Do Not Manufacture At This Facility
  • Manufacture Medical Device
  • Repack or Relabel Medical Device
  • Manufacture Device in the United States for Export Only

• Registration Number: 2953200
• FEI Number: 3001452571
• Name: Medtronic Vascular
• Owner & Operator: MEDTRONIC INC.
• Contact Address: 710 Medtronic Pkwy. ; Minneapolis MN 55432 US
• Official Correspondent:
  • CHRISTINE - BOES
  • x-763-5260396-x
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 3576 Unocal Pl ; Santa Rosa, CA 95403 US
• Establishment Type: Develop Specifications But Do Not Manufacture At This Facility

FDA Filings

Device Company	Device	Date
PMN K220773 Medtronic Vascular	Everest 20 Inflation Device And 3-way Stopcock (AC2200);Everest 30 Inflation Device And 3-way Stopcock (AC3200);Everest 20 Survival Kit Containing:1. Everest 20 Device With 3-way Stopcock, 2. Piton Y-Adaptor ,3. Metal Guidewire Insertion Needle, 4. T	2022-04-13
DQY MEDTRONIC VASCULAR [MEDTRONIC INC.]	Taiga Guide Catheters	2020-03-12
PMN P190008 | PRC Medtronic Vascular [MEDTRONIC INC.]	IN.PACT? AV Paclitaxel-coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter	2019-11-21
PMN K192296 | DQY MEDTRONIC VASCULAR [MEDTRONIC INC.]	Taiga Guide Catheter	2019-09-25
PMN K192296 Medtronic Vascular	Medtronic 6F Taiga Guiding Catheter	2019-09-20
NTE MEDTRONIC VASCULAR [MEDTRONIC INC.]	Guardwire Carotid Embolic Protection Device	2019-03-20
PMN K182957 | OTD Medtronic Vascular [MEDTRONIC INC.]	Heli-FX EndoAnchor System	2018-11-26
PMN K173515 Medtronic Vascular	Admiral Xtreme	2018-04-12
PMN K171866 | DYB Medtronic Vascular [MEDTRONIC INC.]	Sentrant Introducer Sheath with Hydrophilic Coating	2018-01-02
PMN K171427 | OTD Medtronic Vascular [MEDTRONIC INC.]	Heli-FX EndoAnchor System	2017-06-23
PMN P160043 | NIQ Medtronic Vascular [MEDTRONIC INC.]	Resolute Onyx Zotarolimus-Eluting Coronary Stent System	2017-04-28
PMN K162097 | DYB MEDTRONIC VASCULAR [MEDTRONIC INC.]	InTRAkit	2016-11-21
PMN K162097 Medtronic Vascular	InTRAkit	2016-11-17
PMN K162027 | DXC MEDTRONIC VASCULAR [MEDTRONIC INC.]	TRAcelet Compression Device	2016-10-27
PMN K162027 MEDTRONIC VASCULAR	TRAcelet Compression Device	2016-10-21
PMN K161287 | DQO MEDTRONIC VASCULAR [MEDTRONIC INC.]	DxTerity Catheter	2016-08-29
PMN K161287 MEDTRONIC VASCULAR	DxTerity, DxTerity TRA, DxTerity Angio-Kit, DxTerity EZ-Pak, DxTerity TRA Angio-Kit, DxTerity TRA EZ-Pak	2016-08-19
PMN K153038 | MAV MEDTRONIC VASCULAR [MEDTRONIC INC.]	Everest Inflation Device	2016-05-02
PMN K152335 | DXE MEDTRONIC VASCULAR [MEDTRONIC INC.]	Export Advance (new design)	2016-04-11
PMN K141041 | OTD Medtronic Vascular [MEDTRONIC INC.]	Heli-FX EndoAnchor System	2015-07-26
PMN K140036 | OTD Medtronic Vascular [MEDTRONIC INC.]	Heli-FX EndoAnchor System	2015-07-26
PMN K130677 | OTD Medtronic Vascular [MEDTRONIC INC.]	Heli-FX EndoAnchor System	2015-07-26
PMN K121168 | OTD Medtronic Vascular [MEDTRONIC INC.]	Heli-FX Thoracic EndoAnchor System	2015-07-26
PMN DEN100026 | OTD Medtronic Vascular [MEDTRONIC INC.]	Heli-FX EndoAnchor System	2015-07-26
BZN Medtronic Vascular [MEDTRONIC INC.]	Symplicity G3 Renal Denervation RF Generator Cart	2015-04-10
PMN K143316 | DQX MEDTRONIC VASCULAR [MEDTRONIC INC.]	Attain	2015-03-12
PMN P140010 | ONU Medtronic Vascular [MEDTRONIC INC.]	IN.PACT Admiral Paclitaxel-Coated PTA Balloon Catheter	2014-12-30
PMN K140695 | DQX MEDTRONIC VASCULAR [MEDTRONIC INC.]	Cougar" Guidewire, Zinger" Guidewire, Thunder" Guidewire, ProVia" Guidewire, Intuition" Guidewire.	2014-08-29
PMN K132617 | DYB MEDTRONIC VASCULAR [MEDTRONIC INC.]	Input PS Introducer	2014-05-06
PMN K133539 MEDTRONIC VASCULAR	TOTAL ACROSS	2014-03-26
PMN K123990 | DYB Medtronic Vascular [MEDTRONIC INC.]	Sentrant Introducer Sheath	2013-05-03
PMN K123990 MEDTRONIC VASCULAR	SENTRANT INTRODUCER SHEATH WITH HYDROPHILIC COATING	2013-04-26
PMN K123358 MEDTRONIC VASCULAR	PACIFIC PLUS	2013-01-29
PMN K961135 | DYB MEDTRONIC VASCULAR [MEDTRONIC INC.]	10-11F Input TS Introducer	2012-10-15
PMN K940063 | LIT MEDTRONIC VASCULAR [MEDTRONIC INC.]	Piton Y Adaptor, Piton Tri-Adaptor	2012-10-15
PMN K923638 | LIT MEDTRONIC VASCULAR [MEDTRONIC INC.]	PTCA Accessory Pack (Y-Adaptor with Hemostasis Valve, Stretch Insertion Tool)	2012-10-15
PMN K923638 | LIT MEDTRONIC VASCULAR [MEDTRONIC INC.]	PTCA Accessory Pack (Y-Adaptor w/Hemostasis Valve, Stretch Insertion Tool, Steering Handle, Sterile Sleeve)	2012-10-15
PMN K890325 | LIT MEDTRONIC VASCULAR [MEDTRONIC INC.]	Y-Connector with modified Touhy-Borst Adaptor, Stretch Insertion Tool	2012-10-15
PMN K984627 | DQO MEDTRONIC VASCULAR [MEDTRONIC INC.]	4F Siteseer Angiography Catheter	2012-10-12
PMN K932092 | DQO MEDTRONIC VASCULAR [MEDTRONIC INC.]	5F and 6F Siteseer Angiography Catheter	2012-10-12
PMN K884065 | DQO MEDTRONIC VASCULAR [MEDTRONIC INC.]	PWP Catheter	2012-10-12
PMN K791963 | DYB MEDTRONIC VASCULAR [MEDTRONIC INC.]	Mullins Transeptal Catheter and Medtronic Transseptal Catheter Introducer Sheath	2012-10-12
PMN K990707 | DQY MEDTRONIC VASCULAR [MEDTRONIC INC.]	5F and 9F Zuma Guiding Catheter	2012-10-11
PMN K982883 | DQY MEDTRONIC VASCULAR [MEDTRONIC INC.]	8F Zuma Guiding Catheter	2012-10-11
PMN K981198 | DQY MEDTRONIC VASCULAR [MEDTRONIC INC.]	6F Zuma Guiding Catheter	2012-10-11
PMN K942269 | MAV MEDTRONIC VASCULAR [MEDTRONIC INC.]	Everest 20 Inflation Device, Everest 20 Survival Kit	2012-10-11
PMN K120808 | DXE MEDTRONIC VASCULAR [MEDTRONIC INC.]	Export XT and AP Catheter	2012-10-11
PMN K103386 | DQY MEDTRONIC VASCULAR [MEDTRONIC INC.]	5F and 8F Launcher Guiding Catheter	2012-10-11
PMN K060418 | DQY MEDTRONIC VASCULAR [MEDTRONIC INC.]	8F Sherpa NX Guiding Catheter	2012-10-11
PMN K051846 | DQY MEDTRONIC VASCULAR [MEDTRONIC INC.]	7F Sherpa NX Guiding Catheter	2012-10-11
PMN K030671 | DQY MEDTRONIC VASCULAR [MEDTRONIC INC.]	7F and 8F Launcher Biopsy Guiding Catheter	2012-10-11
PMN K022764 | DQY MEDTRONIC VASCULAR [MEDTRONIC INC.]	7F Launcher Guiding Catheter	2012-10-11
PMN K021256 | DQY MEDTRONIC VASCULAR [MEDTRONIC INC.]	6F Launcher Guiding Catheter	2012-10-11
PMN K010579 | DQY MEDTRONIC VASCULAR [MEDTRONIC INC.]	5F and 6F Z2 Guiding Catheter	2012-10-11
PMN K000677 | DQY MEDTRONIC VASCULAR [MEDTRONIC INC.]	7F Zuma Guiding Catheter	2012-10-11
PMN K832607 | DQX MEDTRONIC VASCULAR [MEDTRONIC INC.]	Spring Safety (SOS) Guidewire	2012-09-25
DQX MEDTRONIC VASCULAR [MEDTRONIC INC.]	ProVia 15 Guidewire (Import for Export)	2012-09-25
DQX MEDTRONIC VASCULAR [MEDTRONIC INC.]	Angiography Guide Wires (non-teflon coated)	2012-09-25
DQO MEDTRONIC VASCULAR [MEDTRONIC INC.]	Woven Catheters	2012-09-25
PMN P110013 | NIQ Medtronic Vascular [MEDTRONIC INC.]	Resolute Integrity Zotarolimus-Eluting Coronary Stent System	2012-02-17
PMN P110013 | NIQ Medtronic Vascular [MEDTRONIC INC.]	Resolute Integrity MicroTrac Coronary Stent System	2012-02-17
PMN K082873 | DQX MEDTRONIC VASCULAR [MEDTRONIC INC.]	Angiography Guide Wires - Multiple	2011-10-28
PMN P100040 | MIH Medtronic Vascular [MEDTRONIC INC.]	Valiant Thoracic Stent Graft System	2011-04-12
PMN P100040 | MIH Medtronic Vascular [MEDTRONIC INC.]	Valiant Navion Thoracic Stent Graft System	2011-04-12
PMN P100021 | MIH Medtronic Vascular [MEDTRONIC INC.]	Talent Occluder with Occluder Delivery System	2010-12-22
PMN P100021 | MIH Medtronic Vascular [MEDTRONIC INC.]	Endurant Stent Graft System	2010-12-22
PMN P100021 | MIH Medtronic Vascular [MEDTRONIC INC.]	Endurant IIs Stent Graft System	2010-12-22
PMN P100021 | MIH Medtronic Vascular [MEDTRONIC INC.]	Endurant II Stent Graft System	2010-12-22
PMN P100021 | MIH Medtronic Vascular [MEDTRONIC INC.]	Endurant II AUI Stent Graft System	2010-12-22
PMN K101339 | DQX Medtronic Vascular [MEDTRONIC INC.]	Archer Super Stiff Guidewire	2010-09-02
PMN K101777 MEDTRONIC VASCULAR	PIONEER PLUS CATHETER, MODEL PLUS 120	2010-07-23
PMN K091582 MEDTRONIC VASCULAR	GTX GUIDEWIRE, MODELS TBD-GTX 1, 3,6,9,12, 15	2009-12-04
PMN K083422 MEDTRONIC VASCULAR	6F TAIGA GUIDING CATHETER	2009-02-06
PMN K082873 MEDTRONIC VASCULAR	MEDTRONIC ANGIOGRAPHIC GUIDE WIRES	2009-02-06
PMN K081573 MEDTRONIC VASCULAR	MEDTRONIC EXPORT AP CATHETER	2008-06-27
PMN P030009 | MAF Medtronic Vascular [MEDTRONIC INC.]	Integrity Coronary Stent System	2007-12-10
PMN P030009 | MAF Medtronic Vascular [MEDTRONIC INC.]	Integrity Coronary Stent System on MicroTrac Delivery System	2007-12-10
PMN K050038 | DQY Medtronic Vascular [MEDTRONIC INC.]	Reliant Stent Graft Balloon Catheter	2007-12-07
PMN K960983 | MAV MEDTRONIC VASCULAR [MEDTRONIC INC.]	Everest 30 Inflation Device, Everest 30 Inflation Kit	2007-11-02
PMN K955785 | DYB MEDTRONIC VASCULAR [MEDTRONIC INC.]	4F-9F Input TS Introducer	2007-11-02
DXF MEDTRONIC VASCULAR [MEDTRONIC INC.]	Rashkind Septostomy Catheter	2007-11-02
PMN K071253 MEDTRONIC VASCULAR	AFFINITY PEDIATRIC ARTERIAL FILTER, MODEL S4014 AND WITH CARMEDA BIOACTIVE SURFACE, MODEL CB4014	2007-07-03
PMN K070288 MEDTRONIC VASCULAR	CARDIOBLATE MONOPOLAR PEN, 60813, CARDIOBLATE MONOPOLAR XL, 60814	2007-06-18
PMN K070311 MEDTRONIC VASCULAR	CARDIOBLATE GEMINI SURGICAL ABLATION DEVICE, MODELS 49260 AND 49261	2007-04-24
PMN K061416 MEDTRONIC VASCULAR	SELECTSITE C304 DEFLECTABLE CATHETER SYSTEM, MODELS C304-S59, C304-L69, C304-XS59 & C304-XL74	2006-10-25
PMN K062727 MEDTRONIC VASCULAR	CARDIOBLATE NAVIGATOR TISSUE DISSECTION DEVICE	2006-10-11
PMN K062420 MEDTRONIC VASCULAR	5F SHERPA ACTIVE NX GUIDE CATHETER	2006-09-08
PMN K061958 MEDTRONIC VASCULAR	MEDTRONIC EXPORT XT CATHETER	2006-09-05
PMN K062057 MEDTRONIC VASCULAR	U-CLIP DEVICE, MODEL NC65	2006-08-02
PMN K061127 MEDTRONIC VASCULAR	CG FUTURE ANNULOPLASTY SYSTEM, MODEL 638R	2006-05-23
PMN K060418 MEDTRONIC VASCULAR	8F SHERPA NX GUIDE CATHETER	2006-03-15
PMN K052459 MEDTRONIC VASCULAR	6248VAL ADJUSTABLE VALVE	2006-01-11
PMN K053252 MEDTRONIC VASCULAR	U-CLIP DEVICE, MODELS B140, B160 AND B180	2005-12-16
PMN K051386 MEDTRONIC VASCULAR	MASTERGRAFT PUTTY BONE VOID FILLER	2005-12-16
PMN K052413 MEDTRONIC VASCULAR	TUNA SYSTEM, MODELS 8909, 8929, 8930, 8934	2005-11-17
PMN K051846 MEDTRONIC VASCULAR	7F SHERPA NX GUIDE CATHETER	2005-08-05
PMN K050139 MEDTRONIC VASCULAR	MODIFICATION TO: EXPORT CATHETER	2005-03-22
PMN K043291 MEDTRONIC VASCULAR	CARDIOBLATE DISPERSIVE ELECTRODE ADAPTER (ACCESSORY), MODEL 60884	2004-12-21
PMN K042489 MEDTRONIC VASCULAR	6F Z4 GUIDE CATHETER	2004-12-13
PMN K043080 MEDTRONIC VASCULAR	HEPARIN DOSE RESPONSE CONTROLS, MODEL 306-20 POR	2004-12-03
PMN K042206 MEDTRONIC VASCULAR	PURPLE/BLACK HEPARIN ASSAY CONTROL	2004-10-18
PMN K042175 MEDTRONIC VASCULAR	HEPARINASE HR ACT CONTROL, MODEL 550-12	2004-10-18
PMN K042070 MEDTRONIC VASCULAR	HEPARIN DOSE RESPONSE CARTRIDGE, MODEL 304-20	2004-10-01
PMN K042194 MEDTRONIC VASCULAR	ATTAIN SELECT 6238TEL GUIDE CATHETER SET FOR LEFT-HEART DELIVERY	2004-09-15
PMN K042190 MEDTRONIC VASCULAR	MODEL 6416 TEMPORARY PACING LEAD SYSTEM	2004-09-07
PMN K040812 MEDTRONIC VASCULAR	DETECT SURGICAL PACING AND MAPPING TOOL	2004-09-02
PMN K050139 | DXE MEDTRONIC VASCULAR [MEDTRONIC INC.]	7F Export Catheter	2004-08-26
PMN K041244 MEDTRONIC VASCULAR	POLYGRAM NET BIOFEEDBACK APPLICATION	2004-08-12
PMN K041338 MEDTRONIC VASCULAR	MEDTRONIC OCTOPUS TE STABILIZER & ACCESSORIES	2004-07-19
PMN K040869 MEDTRONIC VASCULAR	EXPORT CATHETER	2004-06-01
PMN K033050 MEDTRONIC VASCULAR	EN CIRCLR AL ADJUSTABLE LOOP MAPPING CATHETER MODELS, 1045AL1, 1045AL2, 1060AL1, 1060AL2	2004-03-26
PMN K040568 MEDTRONIC VASCULAR	POLYETHER URETHANE MATERIAL CHANGE IN NEUROSTIMULATION LEADS	2004-03-25
PMN K945461 | DTL MEDTRONIC VASCULAR [MEDTRONIC INC.]	Piton Y-Pack and Piton Tri-Pak, Torque Handle	2004-03-09
PMN K034058 MEDTRONIC VASCULAR	SPHERICAL TIP CORONARY OSTIAL CANNULA, MODEL 30011	2004-01-29
PMN K032312 MEDTRONIC VASCULAR	ATTAIN 6226DEF DEFLECTABLE CATHETER DELIVERY SYSTEM	2003-10-21
PMN K032926 MEDTRONIC VASCULAR	EKG SPEAKS	2003-10-15
PMN K032138 MEDTRONIC VASCULAR	MEDTRONIC SINGLE USE ESOPHAGEAL MANOMETRIC CATHETER, MEDTRONIC SINGLE USE ANORECTAL MANOMETRIC CATHETER	2003-10-09
PMN K032561 MEDTRONIC VASCULAR	RESUME II LEAD KIT FOR SPINAL CORD STIMULATION (SCS) AND PERIPHERAL NERVE STIMULATION (PNS), RESUME TL LEAD KIT FOR	2003-09-11
PMN K032622 MEDTRONIC VASCULAR	ATTAIN PREVAIL LEFT HEART DELIVERY SYSTEM MODDEL, 6228SYS	2003-09-03
PMN K030671 MEDTRONIC VASCULAR	MEDTRONIOC 7F LAUNCHER BIOPSY GUIDE CATHETER, MODEL LA7RVBB, MEDTRONIC 8F LAUNCHER BIOPSY CATHETER, MODEL LA8RVBB	2003-07-31
PMN K031247 MEDTRONIC VASCULAR	CARDIOBLATE BIPOLAR RADIOFREQUENCY SURGICAL ABLATION SYSTEM	2003-07-17
PMN K031211 MEDTRONIC VASCULAR	ATTAIN PREVAIL STEERABLE CATHETER SET, MODEL 6228CTH	2003-07-17
PMN K024278 MEDTRONIC VASCULAR	PACEART SYSTEM	2003-05-29
PMN K031518 MEDTRONIC VASCULAR	EOPA CAP ELONGATED ONE-PIECE ARTERIAL CANNULA WITH PRESSURE MONITORING LINE, MODELS 774XX, 775XX, 776XX, 777XX, 788XX,	2003-05-22
PMN K031274 MEDTRONIC VASCULAR	MODEL 5071 MYOCARDIAL PACING LEAD	2003-05-22
PMN K030779 MEDTRONIC VASCULAR	5F MEDTRONIC LAUNCHER GUIDE CATHETER	2003-04-24
PMN K030201 MEDTRONIC VASCULAR	MODIFICATION TO EXPORT ASPIRATION CATHETER	2003-03-26
PMN K023878 MEDTRONIC VASCULAR	GUARDWIRE TEMPORARY OCCLUSION AND ASPIRATION SYSTEM	2003-01-24
PMN K024069 MEDTRONIC VASCULAR	ONE PIECE PEDIATRIC ARTERIAL CANNULA, MODEL: 77006, 77106	2003-01-08
PMN K024035 MEDTRONIC VASCULAR	ATTAIN 6218A-AM AMPLATZ GUIDE CATHETER FOR LEFT-HEART DELIVERY	2002-12-30
PMN K024032 MEDTRONIC VASCULAR	ATTAIN 6216A-MP MULTI-PURPOSE GUIDE CATHETER FOR LEFT-HEART DELIVERY	2002-12-30
PMN K023303 MEDTRONIC VASCULAR	EXPORT ASPIRATION CATHETER	2002-10-29
PMN K022238 MEDTRONIC VASCULAR	MYOCARDIAL LEAD IMPLANT TOOL, MODEL 10626	2002-10-09
PMN K022764 MEDTRONIC VASCULAR	7F LAUNCHER GUIDE CATHETER	2002-08-28
PMN K021804 MEDTRONIC VASCULAR	PRECISION PLUS TUNA OFFICE SYSTEM; PRESISION TUNA OFFICE SYSTEM; PROVU TUNA SYSTEM	2002-08-28
PMN K021902 MEDTRONIC VASCULAR	MAGELLAN AUTOLOGUS PLATELET SEPARATOR, MAG100, MAGELLAN AUTOLOGOUS PLATELET SEPARATOR DEISPOSABLE KIT, MKT300	2002-08-12
PMN K021589 MEDTRONIC VASCULAR	ATTAIN ACCESS 6218A LEFT-HEART DELIVERY SYSTEM, MODEL 6218	2002-05-30
PMN K021587 MEDTRONIC VASCULAR	ATTAIN LDS 6216A LEFT-HEART DELIVERY SYSTEM, MODEL 6216A	2002-05-30
PMN K021256 MEDTRONIC VASCULAR	Z3 GUIDE CATHETER	2002-05-17
PMN K013517 MEDTRONIC VASCULAR	10600 DEFLECTABLE CATHETER SYSTEM, MODEL 10600	2002-04-25
PMN K013392 MEDTRONIC VASCULAR	CARDIOBLATE SURGICAL ABLATION PEN, MODEL 60811C; CARDIOBLATE SURGICAL ABLATION GENERATOR, MODEL 60880	2002-01-25
PMN K010579 MEDTRONIC VASCULAR	STENT SUPPORT GUIDE CATHETER	2001-11-21
PMN K012225 MEDTRONIC VASCULAR	ATTAIN 6215 VENOGRAM BALLOON CATHETER	2001-08-28
PMN K012130 MEDTRONIC VASCULAR	ATTAIN LDS 6216 LEFT-HEART DELIVERY SYSTEM	2001-08-28
PMN K012083 MEDTRONIC VASCULAR	ATTAIN ACCESS 6218 LEFT-HEART DELIVERY SYSTEM, MODEL 6218	2001-08-28
PMN K012538 MEDTRONIC VASCULAR	TUBING AND CONNECTORS WITH TRILLIUM BIOPASSIVE SURFACE	2001-08-23
PMN K012460 MEDTRONIC VASCULAR	MODEL 6495 BIPOLAR TEMPORARY MYOCARDIAL PACING LEAD	2001-08-14
PMN K012459 MEDTRONIC VASCULAR	MODEL 6494 UNIPOLAR TEMPORARY MYOCARDIAL PACING WIRE	2001-08-14
PMN K012458 MEDTRONIC VASCULAR	MODEL 6492 UNIPOLAR TEMPORARY ATRIAL PACING LEAD	2001-08-14
PMN K012454 MEDTRONIC VASCULAR	MODEL 6491 UNIPOLAR PEDIATRIC TEMPORARY PACING LEAD	2001-08-14
PMN K012452 MEDTRONIC VASCULAR	MODEL 6500 UNIPOLAR TEMORARY MYOCARDIAL PACING LEAD	2001-08-14
PMN K010300 MEDTRONIC VASCULAR	MEDTRONIC MODEL 7495LZ LOW IMPEDANCE EXTENSION	2001-08-01
PMN K011395 MEDTRONIC VASCULAR	MEDTRONIC COLVIN-GALLOWAY FUTURE ANNULOPLASTY BAND, MODEL 638B	2001-07-12
PMN K011864 MEDTRONIC VASCULAR	TRILLIUM MYOTHERM XP CARDIOPLEGIA DELIVERY SYSTEM, MODELS 41, 41-B	2001-07-09
PMN K011584 MEDTRONIC VASCULAR	MEDTRONIC SPINAL CORD STIMULATION AND PERIPHERAL NERVE STIMULATION SYSTEMS FOR PAIN RELIEF	2001-06-22
PMN K011098 MEDTRONIC VASCULAR	REVEAL PLUS INSERTABLE LOOP RECORDER SYSTEM MODEL 9526 IMPLANTABLE RECORDER AND MODEL 6191 PATIENT ACTIVATOR	2001-05-04
PMN K010906 MEDTRONIC VASCULAR	MEDTRONIC STYLET KIT, MODELS 6282, 6293, AND 6254	2001-04-05
PMN K003667 MEDTRONIC VASCULAR	REVEAL PLUS INSERTABLE LOOP RECORDER	2001-02-14
PMN K003535 MEDTRONIC VASCULAR	STYLET KIT, MODELS 6254,6282,6293	2001-02-08
PMN K003724 MEDTRONIC VASCULAR	CBMYOTHERM XP CARDIOPLEGIA DELIVERY SYSTEM WITH CARMEDA BIOACTIVE SURFACE, MODELS CB41 AND CB41-B	2000-12-21
PMN K001969 MEDTRONIC VASCULAR	GT2 FUSION GUIDE WIRE, MODEL NTLHLJ180,NTLHLS180, NTLHLJ300, NTLHLS300	2000-08-16
PMN K960056 | DQO MEDTRONIC VASCULAR [MEDTRONIC INC.]	Pro-Flo Angiography Catheter	1995-01-30
PMN K042489 | DQY MEDTRONIC VASCULAR [MEDTRONIC INC.]	6F Sherpa Guiding Catheter	1995-01-30

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• Medtronic8200 Coral Seast. N.e.mounds View, MN 55112 PMA NumberP100047 Supplement NumberS205 Date Received01/19/2023 Decision Date02/02/2023 Product Code DSQ  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Medtronic, Inc.710 Medtronic Parkwayminneapolis,, MN 55432 PMA NumberP130021 Supplement NumberS131 Date Received01/27/2023 Decision Date01/29/2023 Product Code NPT  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT8200 Coral Sea Street N.e.mounds View, MN 55112 PMA NumberP010031 Supplement NumberS812 Date Received01/19/2023 Decision Date01/26/2023 Product Code NIK  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT8200 Coral Sea Street N.e.ms Mvs11mounds View, MN 55112 PMA NumberP980016 Supplement NumberS846 Date Received01/19/2023 Decision Date01/26/2023 Product Code LWS  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Medtronic CryoCath LP8200 Coral Sea Streetmounds View, MN 55112 PMA NumberP020045 Supplement NumberS102 Date Received12/22/2022 Decision Date01/19/2023 Product Code LPB  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Medtronic CryoCath LP8200 Coral Sea Streetms Mvs46mounds View, MN 55112 PMA NumberP100010 Supplement NumberS134 Date Received12/21/2022 Decision Date01/19/2023 Product Code OAE  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Medtronic CryoCath LP8200 Coral Sea Streetms Mvs46mounds View, MN 55112 PMA NumberP100010 Supplement NumberS135 Date Received12/22/2022 Decision Date01/19/2023 Product Code OAE  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• MEDTRONIC Inc.8200 Coral Sea Street Nems Mv S11mounds View, MN 55112 PMA NumberP980035 Supplement NumberS738 Date Received01/09/2023 Decision Date01/17/2023 Product Code NVZ  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• MEDTRONIC Inc.8200 Coral Sea Street Nems Mv S11mounds View, MN 55112 PMA NumberP010015 Supplement NumberS512 Date Received01/09/2023 Decision Date01/17/2023 Product Code LWP  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Medtronic, Inc.8200 Coral Sea Street N.e.mounds View, MN 55112 PMA NumberP930039 Supplement NumberS248 Date Received01/09/2023 Decision Date01/16/2023 Product Code NVN  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT8200 Coral Sea Street N.e.mounds View, MN 55112 PMA NumberP830061 Supplement NumberS211 Date Received01/09/2023 Decision Date01/16/2023 Product Code NVN  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• MEDTRONIC Inc.8200 Coral Sea Street Nems Mv S11mounds View, MN 55112 PMA NumberP920015 Supplement NumberS274 Date Received01/09/2023 Decision Date01/16/2023 Product Code NVY  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• MEDTRONIC Inc.8200 Coral Sea Street Nems Mv S11mounds View, MN 55112 PMA NumberP980035 Supplement NumberS737 Date Received01/09/2023 Decision Date01/16/2023 Product Code NVZ  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT8200 Coral Sea Street N.e.mounds View, MN 55112 PMA NumberP010031 Supplement NumberS811 Date Received01/06/2023 Decision Date01/13/2023 Product Code NIK  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT8200 Coral Sea Street N.e.ms Mvs11mounds View, MN 55112 PMA NumberP980016 Supplement NumberS845 Date Received01/06/2023 Decision Date01/13/2023 Product Code LWS  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• MEDTRONIC Inc.8200 Coral Sea Street Nems Mv S11mounds View, MN 55112 PMA NumberP980035 Supplement NumberS736 Date Received12/15/2022 Decision Date01/04/2023 Product Code NVZ  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• MEDTRONIC VASCULAR INC3033 Campus Driveplymouth, MN 55441 PMA NumberP060001 Supplement NumberS035 Date Received11/15/2022 Decision Date12/15/2022 Product Code NIM  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• MEDTRONIC VASCULAR INC3033 Campus Driveplymouth, MN 55441 PMA NumberP110023 Supplement NumberS036 Date Received11/15/2022 Decision Date12/15/2022 Product Code NIP  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• MEDTRONIC Inc.8200 Coral Sea Street Nems Mv S11mounds View, MN 55112 PMA NumberP150033 Supplement NumberS164 Date Received12/06/2022 Decision Date12/12/2022 Product Code PNJ  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Medtronic CryoCath LP8200 Coral Sea Streetms Mvs46mounds View, MN 55112 PMA NumberP100010 Supplement NumberS133 Date Received11/14/2022 Decision Date12/07/2022 Product Code OAE  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Medtronic Vascular3576 Unocal Placesanta Rosa, CA 95403 PMA NumberP100040 Supplement NumberS055 Date Received11/29/2022 Decision Date12/01/2022 Product Code MIH  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Medtronic Vascular Inc.3576 Unocal Placesanta Rosa, CA 95403 PMA NumberP190008 Supplement NumberS022 Date Received11/29/2022 Decision Date12/01/2022 Product Code PRC  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• MEDTRONIC Inc.3576 Unocal Plsanta Rosa, CA 95403 PMA NumberP140010 Supplement NumberS071 Date Received11/29/2022 Decision Date12/01/2022 Product Code ONU  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• MEDTRONIC VASCULAR3576 Unocal Placesanta Rosa, CA 95403 PMA NumberP160043 Supplement NumberS064 Date Received11/29/2022 Decision Date12/01/2022 Product Code NIQ  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Medtronic, Inc.710 Medtronic Parkwayminneapolis,, MN 55432 PMA NumberP130021 Supplement NumberS128 Date Received11/29/2022 Decision Date12/01/2022 Product Code NPT  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Medtronic, Inc.710 Medtronic Parkwayminneapolis,, MN 55432 PMA NumberP130021 Supplement NumberS129 Date Received11/30/2022 Decision Date12/01/2022 Product Code NPT  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Medtronic, Inc.3576 Unocal Placebuilding Asanta Rosa, CA 95403 PMA NumberP200046 Supplement NumberS013 Date Received11/29/2022 Decision Date12/01/2022 Product Code NPV  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• MEDTRONIC VASCULAR INC3033 Campus Driveplymouth, MN 55441 PMA NumberP140018 Supplement NumberS036 Date Received11/29/2022 Decision Date12/01/2022 Product Code PJQ  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Medtronic Vascular3576 Unocal Placesanta Rosa, CA 95403 PMA NumberP100021 Supplement NumberS111 Date Received11/29/2022 Decision Date12/01/2022 Product Code MIH  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Medtronic Vascular3576 Unocal Placesanta Rosa, CA 95403 PMA NumberP100021 Supplement NumberS109 Date Received11/01/2022 Decision Date11/30/2022 Product Code MIH  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• MEDTRONIC Inc.8200 Coral Sea Street Nems Mv S11mounds View, MN 55112 PMA NumberP150033 Supplement NumberS163 Date Received11/21/2022 Decision Date11/28/2022 Product Code PNJ  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• MEDTRONIC VASCULAR3576 Unocal Placesanta Rosa, CA 95403 PMA NumberP160043 Supplement NumberS063 Date Received11/18/2022 Decision Date11/28/2022 Product Code NIQ  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Medtronic Vascular3576 Unocal Placesanta Rosa, CA 95403 PMA NumberP100021 Supplement NumberS110 Date Received11/18/2022 Decision Date11/28/2022 Product Code MIH  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• MEDTRONIC Inc.8200 Coral Sea Street Nemvs83mounds View, MN 55112 PMA NumberP140017 Supplement NumberS023 Date Received11/16/2022 Decision Date11/28/2022 Product Code NPV  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Medtronic, Inc.710 Medtronic Parkwayminneapolis,, MN 55432 PMA NumberP130021 Supplement NumberS127 Date Received11/18/2022 Decision Date11/28/2022 Product Code NPT  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT8200 Coral Sea Street N.e.mounds View, MN 55112 PMA NumberP030036 Supplement NumberS141 Date Received11/21/2022 Decision Date11/28/2022 Product Code NVN  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Medtronic Vascular3576 Unocal Placesanta Rosa, CA 95403 PMA NumberP100040 Supplement NumberS054 Date Received11/18/2022 Decision Date11/28/2022 Product Code MIH  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• MEDTRONIC Inc.8200 Coral Sea Street Nems Mv S11mounds View, MN 55112 PMA NumberP010015 Supplement NumberS510 Date Received11/16/2022 Decision Date11/22/2022 Product Code LWP  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• MEDTRONIC Inc.8200 Coral Sea Street Nems Mv S11mounds View, MN 55112 PMA NumberP980035 Supplement NumberS735 Date Received11/16/2022 Decision Date11/22/2022 Product Code NVZ  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• MEDTRONIC Inc.8200 Coral Sea Street Nems Mv S11mounds View, MN 55112 PMA NumberP980035 Supplement NumberS734 Date Received11/16/2022 Decision Date11/22/2022 Product Code NVZ  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT8200 Coral Sea Street N.e.mounds View, MN 55112 PMA NumberP850089 Supplement NumberS163 Date Received11/16/2022 Decision Date11/22/2022 Product Code NVN  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• MEDTRONIC Inc.8200 Coral Sea Street Nems Mv S11mounds View, MN 55112 PMA NumberP950024 Supplement NumberS105 Date Received11/16/2022 Decision Date11/22/2022 Product Code NVN  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• MEDTRONIC Inc.8200 Coral Sea Street Nems Mv S11mounds View, MN 55112 PMA NumberP010015 Supplement NumberS511 Date Received11/16/2022 Decision Date11/22/2022 Product Code LWP  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Medtronic, Inc8200 Coral Sea Street Nemounds View, MN 55112 PMA NumberP090013 Supplement NumberS325 Date Received11/16/2022 Decision Date11/22/2022 Product Codes NVN LWP  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• MEDTRONIC Inc.710 Medtronic Parkway Neminneapolis, MN 55432 PMA NumberP080006 Supplement NumberS173 Date Received11/16/2022 Decision Date11/22/2022 Product Code OJX  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Medtronic, Inc.8200 Coral Sea Street N.e.mounds View, MN 55112 PMA NumberP930039 Supplement NumberS247 Date Received11/16/2022 Decision Date11/22/2022 Product Code NVN  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT8200 Coral Sea Street N.e.ms Mvs11mounds View, MN 55112 PMA NumberP980016 Supplement NumberS841 Date Received11/16/2022 Decision Date11/22/2022 Product Code LWS  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT8200 Coral Sea Street N.e.mounds View, MN 55112 PMA NumberP030036 Supplement NumberS140 Date Received11/16/2022 Decision Date11/22/2022 Product Code NVN  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• MEDTRONIC Inc.8200 Coral Sea Streetms Mvs11mounds View, MN 55112 PMA NumberP980050 Supplement NumberS139 Date Received11/16/2022 Decision Date11/22/2022 Product Code LWS  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• MEDTRONIC Inc.8200 Coral Sea Street Nems Mv S11mounds View, MN 55112 PMA NumberP920015 Supplement NumberS273 Date Received11/16/2022 Decision Date11/22/2022 Product Code NVY  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT8200 Coral Sea Street N.e.mounds View, MN 55112 PMA NumberP010031 Supplement NumberS808 Date Received11/16/2022 Decision Date11/22/2022 Product Code NIK  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• MEDTRONIC Inc.8200 Coral Sea Street Nems Mv S11mounds View, MN 55112 PMA NumberP060039 Supplement NumberS112 Date Received11/16/2022 Decision Date11/22/2022 Product Code OJX  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT8200 Coral Sea Street N.e.mounds View, MN 55112 PMA NumberP830061 Supplement NumberS210 Date Received11/16/2022 Decision Date11/22/2022 Product Code NVN  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Medtronic, Inc.8200 Coral Sea Street N.e.mounds View, MN 55112 PMA NumberP890003 Supplement NumberS458 Date Received11/16/2022 Decision Date11/22/2022 Product Code NVZ  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• MEDTRONIC Inc.8200 Coral Sea Street Nems Mv S11mounds View, MN 55112 PMA NumberP980035 Supplement NumberS733 Date Received11/14/2022 Decision Date11/18/2022 Product Code NVZ  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Medtronic Inc.8200 Coral Sea Streetmounds View, MN 55112 PMA NumberP200028 Supplement NumberS014 Date Received10/17/2022 Decision Date11/16/2022 Product Code OAE  Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track No User Fee Supplement Reason Postapproval Study Protocol Expedited Review Granted? No
• MEDTRONIC Inc.8200 Coral Sea Street Nems Mv S11mounds View, MN 55112 PMA NumberP150033 Supplement NumberS160 Date Received11/04/2022 Decision Date11/11/2022 Product Code PNJ  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Medtronic CryoCath LP8200 Coral Sea Streetms Mvs46mounds View, MN 55112 PMA NumberP100010 Supplement NumberS132 Date Received10/28/2022 Decision Date11/09/2022 Product Code OAE  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• MEDTRONIC VASCULAR INC3033 Campus Driveplymouth, MN 55441 PMA NumberP140018 Supplement NumberS035 Date Received10/12/2022 Decision Date11/08/2022 Product Code PJQ  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• MEDTRONIC Inc.8200 Coral Sea Street Nems Mv S11mounds View, MN 55112 PMA NumberP150033 Supplement NumberS155 Date Received10/03/2022 Decision Date11/04/2022 Product Code PNJ  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Medtronic, Inc.710 Medtronic Parkwayminneapolis,, MN 55432 PMA NumberP130021 Supplement NumberS123 Date Received10/25/2022 Decision Date11/03/2022 Product Code NPT  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• MEDTRONIC Inc.8200 Coral Sea Street Nems Mv S11mounds View, MN 55112 PMA NumberP150033 Supplement NumberS156 Date Received10/24/2022 Decision Date11/03/2022 Product Code PNJ  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Medtronic Vascular3576 Unocal Placesanta Rosa, CA 95403 PMA NumberP100040 Supplement NumberS053 Date Received10/31/2022 Decision Date11/01/2022 Product Code MIH  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Medtronic, Inc.3576 Unocal Placebuilding Asanta Rosa, CA 95403 PMA NumberP200046 Supplement NumberS012 Date Received10/31/2022 Decision Date11/01/2022 Product Code NPV  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Medtronic, Inc.710 Medtronic Parkwayminneapolis,, MN 55432 PMA NumberP130021 Supplement NumberS126 Date Received10/31/2022 Decision Date11/01/2022 Product Code NPT  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• MEDTRONIC Inc.3576 Unocal Plsanta Rosa, CA 95403 PMA NumberP140010 Supplement NumberS070 Date Received10/31/2022 Decision Date11/01/2022 Product Code ONU  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Medtronic Vascular3576 Unocal Placesanta Rosa, CA 95403 PMA NumberP100021 Supplement NumberS108 Date Received10/31/2022 Decision Date11/01/2022 Product Code MIH  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• MEDTRONIC Inc.8200 Coral Sea Street Nems Mv S11mounds View, MN 55112 PMA NumberP150033 Supplement NumberS157 Date Received10/31/2022 Decision Date11/01/2022 Product Code PNJ  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Medtronic Vascular Inc.3576 Unocal Placesanta Rosa, CA 95403 PMA NumberP190008 Supplement NumberS021 Date Received10/31/2022 Decision Date11/01/2022 Product Code PRC  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• MEDTRONIC VASCULAR3576 Unocal Placesanta Rosa, CA 95403 PMA NumberP160043 Supplement NumberS062 Date Received10/31/2022 Decision Date11/01/2022 Product Code NIQ  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Medtronic, Inc.710 Medtronic Parkwayminneapolis,, MN 55432 PMA NumberP130021 Supplement NumberS125 Date Received10/28/2022 Decision Date11/01/2022 Product Code NPT  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Medtronic8200 Coral Seast. N.e.mounds View, MN 55112 PMA NumberP100047 Supplement NumberS202 Date Received10/03/2022 Decision Date10/31/2022 Product Code DSQ  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Medtronic Vascular3576 Unocal Placesanta Rosa, CA 95403 PMA NumberP100040 Supplement NumberS052 Date Received09/27/2022 Decision Date10/27/2022 Product Code MIH  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Medtronic, Inc.8200 Coral Sea Street N.e.mounds View, MN 55112 PMA NumberP930039 Supplement NumberS246 Date Received10/19/2022 Decision Date10/25/2022 Product Code NVN  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• MEDTRONIC Inc.8200 Coral Sea Street Nems Mv S11mounds View, MN 55112 PMA NumberP010015 Supplement NumberS509 Date Received10/24/2022 Decision Date10/25/2022 Product Code LWP  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT8200 Coral Sea Street N.e.mounds View, MN 55112 PMA NumberP010031 Supplement NumberS806 Date Received10/24/2022 Decision Date10/25/2022 Product Code NIK  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• MEDTRONIC Inc.8200 Coral Sea Street Nems Mv S11mounds View, MN 55112 PMA NumberP920015 Supplement NumberS272 Date Received10/19/2022 Decision Date10/25/2022 Product Code NVY  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• MEDTRONIC Inc.8200 Coral Sea Street Nems Mv S11mounds View, MN 55112 PMA NumberP980035 Supplement NumberS731 Date Received10/19/2022 Decision Date10/25/2022 Product Code NVZ  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• MEDTRONIC Inc.8200 Coral Sea Street Nems Mv S11mounds View, MN 55112 PMA NumberP980035 Supplement NumberS732 Date Received10/24/2022 Decision Date10/25/2022 Product Code NVZ  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT8200 Coral Sea Street N.e.ms Mvs11mounds View, MN 55112 PMA NumberP980016 Supplement NumberS840 Date Received10/24/2022 Decision Date10/25/2022 Product Code LWS  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT8200 Coral Sea Street N.e.mounds View, MN 55112 PMA NumberP830061 Supplement NumberS209 Date Received10/19/2022 Decision Date10/25/2022 Product Code NVN  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• MEDTRONIC ATS MEDICAL, INC.3800 Annapolis Lane, Suite 175plymouth, MN 55447 PMA NumberP990046 Supplement NumberS065 Date Received09/26/2022 Decision Date10/21/2022 Product Code LWQ  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT8200 Coral Sea Street N.e.mounds View, MN 55112 PMA NumberP010031 Supplement NumberS804 Date Received10/18/2022 Decision Date10/20/2022 Product Code NIK  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT8200 Coral Sea Street N.e.ms Mvs11mounds View, MN 55112 PMA NumberP980016 Supplement NumberS838 Date Received10/18/2022 Decision Date10/20/2022 Product Code LWS  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• MEDTRONIC Inc.8200 Coral Sea Street Nems Mv S11mounds View, MN 55112 PMA NumberP010015 Supplement NumberS508 Date Received10/18/2022 Decision Date10/20/2022 Product Code LWP  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT8200 Coral Sea Street N.e.mounds View, MN 55112 PMA NumberP010031 Supplement NumberS803 Date Received10/11/2022 Decision Date10/14/2022 Product Code NIK  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• MEDTRONIC Inc.8200 Coral Sea Street Nems Mv S11mounds View, MN 55112 PMA NumberP010015 Supplement NumberS507 Date Received10/11/2022 Decision Date10/14/2022 Product Code LWP  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT8200 Coral Sea Street N.e.ms Mvs11mounds View, MN 55112 PMA NumberP980016 Supplement NumberS837 Date Received10/11/2022 Decision Date10/14/2022 Product Code LWS  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Medtronic Vascular3576 Unocal Placesanta Rosa, CA 95403 PMA NumberP100021 Supplement NumberS107 Date Received09/28/2022 Decision Date10/13/2022 Product Code MIH  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• MEDTRONIC Inc.8200 Coral Sea Street Nems Mv S11mounds View, MN 55112 PMA NumberP150033 Supplement NumberS154 Date Received09/26/2022 Decision Date10/12/2022 Product Code PNJ  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Medtronic Inc.8200 Coral Sea Streetmounds View, MN 55112 PMA NumberP200028 Supplement NumberS012 Date Received07/15/2022 Decision Date10/12/2022 Product Code OAE  Advisory Committee Cardiovascular Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No
• Medtronic Vascular Inc.3576 Unocal Placesanta Rosa, CA 95403 PMA NumberP190008 Supplement NumberS020 Date Received09/29/2022 Decision Date10/11/2022 Product Code PRC  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• MEDTRONIC Inc.3576 Unocal Plsanta Rosa, CA 95403 PMA NumberP140010 Supplement NumberS068 Date Received09/29/2022 Decision Date10/11/2022 Product Code ONU  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Medtronic, Inc.8200 Coral Sea Street N.e.mounds View, MN 55112 PMA NumberP890003 Supplement NumberS456 Date Received07/25/2022 Decision Date10/06/2022 Product Code NVZ  Advisory Committee Cardiovascular Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No
• MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT8200 Coral Sea Street N.e.mounds View, MN 55112 PMA NumberP030036 Supplement NumberS139 Date Received07/22/2022 Decision Date10/03/2022 Product Code NVN  Advisory Committee Cardiovascular Clinical TrialsNCT01524276 Supplement Typenormal 180 Day Track Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No
• Medtronic Vascular3576 Unocal Placesanta Rosa, CA 95403 PMA NumberP110013 Supplement NumberS117 Date Received04/07/2022 Decision Date09/29/2022 Product Code NIQ  Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track No User Fee Supplement Reason Labeling Change - Pas Expedited Review Granted? No

Related Finance Registrations

NCAGE Code	59DG1	MEDTRONIC VASCULAR
CAGE Code	59DG1	MEDTRONIC VASCULAR