FDA.reportPublic FDA data

BIOTRONIK, INC.

Matched from indexed company URL: BIOTRON LTD.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
10282321028232BIOTRONIK, INC.1Y2026-01-016024 JEAN RD. LAKE OSWEGO OR US 97035
80438923002808050BIOTRONIK AG1N2026-01-01ACKERSTRASSE 6 BULACH Zurich CH CH-8180
30101311373010131137BIOTRONIX HEALTHCARE INDUSTRIES INC.1Y2026-01-014700 Millenia Blvd Ste 500 Orlando FL US 32839
30270631903027063190BIOTRONIK NRO, INC.1Y2026-01-016024 Jean Road Lake Oswego OR US 97035
30317550193031755019Biotronics 3D Limited1N2026-01-0110 Upper Berkley Street London London, City of GB W1H 7PE

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
07640130433779Passeo-14 - 3.5/140/150612-423-1738FDA.US.Agent@teleflex.com
07640130433786Passeo-14 - 4/140/150612-423-1738FDA.US.Agent@teleflex.com
07640130433809Passeo-14 - 2/180/150612-423-1738FDA.US.Agent@teleflex.com
07640130433816Passeo-14 - 2.5/180/150612-423-1738FDA.US.Agent@teleflex.com
07640130433823Passeo-14 - 3/180/150612-423-1738FDA.US.Agent@teleflex.com
07640130433861Passeo-14 - 2/220/150612-423-1738FDA.US.Agent@teleflex.com
07640130433878Passeo-14 - 2.5/220/150612-423-1738FDA.US.Agent@teleflex.com
07640130433885Passeo-14 - 3/220/150612-423-1738FDA.US.Agent@teleflex.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
281911713920620P980023PHYLAX IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEMLWS1998-10-27
281911309454949P950037DROMOS DR/DR-A AND DROMOS SR/SR-B CARDIAC PACING SYSTEMSDXY1996-10-11
281911723237467P820076DIPLOS MODEL 05 A & BLWP1984-02-15
3161962054914776P210037Prospera Spinal Cord Stimulation (SCS) System, Resilience Percutaneous Lead, HomeStream Remote ManagementLGW2023-03-31
281911234382442P170030ORSIRO Sirolimus Eluting Coronary Stent SystemNIQ2019-02-22
839351263247262P170030ORSIRO Sirolimus Eluting Coronary Stent SystemNIQ2019-02-22
839351895965527P160025ASTRON PULSAR STENT SYSTEM, PULSAR-18 STENT SYSTEMNIP2017-03-23
839351632727540P160003PRO-KINETIC ENERGY COBALT CHROMIUM (CoCr) CORONARY STENT SYSTEMMAF2017-02-14
839351793172198P140030ASTRON PERIPHERAL SELF-EXPANDING NITINOL STENT SYSTEMNIO2015-12-17
281911183288798P070008STRATOS LV CRT-P AND STRATOS LV-T CRT-P, COROX OTW BP LEAD AND COROX OTW-S BP LEADNKE2008-05-12
281911754526466P050023TUPOS LV/ATX & KRONOS LV-T CRT-D & COROX OWT STEROID LV PACING LEADMRM2006-08-10
281911874963309P000009PHYLAX AV ICD SYSTEMMRM2000-09-29
1546831424219406K993118BIOTEQUE A.V. FISTULA NEEDLE SETFIE1999-12-17
281911843737205K982272GALEO HS 014 MODEL 117 130, GALEO S 014 MODEL 115 488, GALEAO M 014 MODEL 114156, GALEO F 014 MODEL 115 487 GALEO HF 018DQX1999-01-08
281911413560754K971930BK-N SEALING CAPDTD1997-08-14
281911436236894K970204BK-A; BK-B; BK-IS SEALING CAPDTD1997-04-29
281911853114577K964190ERA 300 DUAL CHAMBER PACING SYSTEM ANALYZERDTE1997-07-10
839351284326705K250706Passeo-35 Xeo Peripheral Dilatation Catheter; Passeo-18 Peripheral Dilatation Catheters; Passeo-14 Peripheral Dilatation Catheter; Oscar Peripheral Multifunctional Catheter System; Pantera Pro Percutaneous Transluminal Coronary Angioplasty Catheter; Pantera LEO Percutaneous Transluminal Coronary Angioplasty (PTCA) CatheterLIT2025-04-04
281911998574796K250706Passeo-35 Xeo Peripheral Dilatation Catheter; Passeo-18 Peripheral Dilatation Catheters; Passeo-14 Peripheral Dilatation Catheter; Oscar Peripheral Multifunctional Catheter System; Pantera Pro Percutaneous Transluminal Coronary Angioplasty Catheter; Pantera LEO Percutaneous Transluminal Coronary Angioplasty (PTCA) CatheterLIT2025-04-04
3302992032916367K240839OpenRad CloudLLZ2024-04-24
281911336713106K240787Selectra 3D Lead Delivery System (443624-443629, 451789-451791); Selectra Slitter Tool (383119); Selectra Accessory Kit (375518)DQY2024-09-12
281911437751083K230375BIOMONITOR IVMXD2023-05-19
1546831507583818K223323Blood Collection Needle (with/without Needle Holder)JKA2023-03-24
1546831321395069K222141Safety Blood Collection Needle (Without Needle Holder)JKA2022-10-21
1546831710232589K222124Sterile Hypodermic Syringe with/without Needle, Hypodermic NeedleFMI2022-11-04
281911382647764K222037Selectra Lead Implantation SystemDQY2022-07-19
281911775582339K221856BIOMONITOR IIIm, BIOMONITOR IIIMXD2022-07-27
1546831546010858K221521Disposable Safety LancetFMK2022-10-28
1546831120345318K214075Safety Blood Collection / Infusion Set (with/without needle holder), Blood Collection / Infusion Set (with/without needle holder)FMI2022-04-12
281912015623492K212593ViaCath, AcQRate Dx Steerable CatheterDRF2021-10-15
1546831868062168K211555Hypodermic Safety Needle; Hypodermic Safety Needle with SyringeMEG2021-10-18
1546832031020193K210745Heel Incision Safety LancetFMK2021-08-26
1546831385219970K202698Prefilled SyringeEZL2020-12-15
281911478818398K201445MultiCath, AcQRate Dx Fixed Curve CatheterDRF2021-09-02
281911816737245K200444Biomonitor III, Biomonitor IIImMXD2020-04-23
1546831783995716K200027Blood Collection Needle with/without Holder, Safety Blood Collection Needle with/without Holder, Luer Access Device-holder with Preattached Multiple Sample AdapterJKA2020-09-09
281911985179832K193474Selectra 3D Outer Guiding CathetersDQY2020-10-16
281911254174487K192996Selectra Catheters, Selectra Accessory Kit, Selectra Slitter ToolDQY2019-11-21
1546831308500524K192230MF SAFECATHFOZ2020-04-23
281911095329053K191469Biotronik StyletsDRB2019-08-01
281912027468016K190548BIOMONITOR III, Remote Assistant IIIMXD2019-07-05
1546831705465149K190183Hypodermic Safety Needle, Hypodermic Safety Needle with SyringeMEG2019-10-04
281911310742017K183265Selectra Catheters, Selectra Accessory KitDQY2018-12-13
1546831208024196K181276CONOD Enteral Feeding SetsPIF2018-07-12
1546832010917268K173847Disposable Ultra Reinforced Surgical GownFYA2019-01-16
1546831692396113K172763Blood Collecting Needle, Safety Blood Collecting Needle, Blood Collecting Needle with Holder, Safety Blood Collecting Needle with Holder, Blood Collecting Set, Safety Blood Collecting Set, Blood Collecting Set with Holder, Safety Blood Collecting Set with HolderJKA2018-06-04
839351657566336K163660Pantera LEOLOX2017-01-26
1546831156928378K162188Enteral Syringe with ENFit Connector (10 ml to 60 ml), Enteral Syringe with ENFit Low Dose Tip (1 ml to 5 ml)PNR2016-09-22
839351056585236K160985Pantera ProLOX2016-10-07
1546831435944067K153496Disposable Surgical Face MaskFXX2016-06-15
839351855338479K153197Fortress Introducer Sheath SYstemDYB2016-01-11
281911108246177K152995BioMonitor 2-AF, BioMonitor 2-SMXD2016-04-11
839351927430492K152240Passeo-14 Peripheral Dilatation CatheterLIT2015-10-08
1546831023009379K151991
281911632616329K151409Selectra Catheters and Selectra Accessory KitDQY2015-08-07
281911092479465K143503BioMonitorMXD2015-03-19
1546831232328157K142797I.V. CatheterFOZ2015-06-18
839351236732730K142379Passeo-35 PTA CatheterLIT2014-12-05
1546831144679180K140356SUMMED HIGH PRESSURE LINEDQO2015-03-20
1546831867776363K140237DISPOSABLE NEBULIZER SETCAF2015-01-08
1546832026997030K133795SUMMED INFLATION DEVICE KITMAV2014-12-12
1546831999871467K133343WONDFO RAPID STREP A TESTGTY2014-01-31
1546831788933873K133058INSULIN PEN NEEDLEFMI2014-02-25
1546831075731459K132709VR MEDICAL HEAT AND MOISTURE EXCHANGER AND FILTERCAH2014-07-30
1546831332878458K131754WONDFO COCAINE URINE TEST (COC 100), WONDFO CANNABINOIDS URINE TEST (THC 40)DIO2013-07-31
1546831415636358K131511DISPOSABLE CIRCULAR STAPLER, DISPOSABLE CURVED CUTTER STAPLER, DISPOSABLE LINEAR STAPLERS AND RELOADS, DISPOSABLE HEMORRGDW2013-07-05
1546831860856177K130737SYNTHETIC ABSORBABLE SUTUREGAM2014-01-14
1546831836863314K130735SYNTHETIC ABSORBABLE SUTUREGAM2014-01-14
1546831869697198K130273PANPAC VAGINAL DILATORSHDX2013-08-08
839351856160047K130146SYNTHES SYNFLATE VERTEVRAL BALLOON SYSTEMNDN2013-05-20
1546831481277705K130087PANPAC WORD/BARTHOLIN CATHETERKNA2014-01-10
1546831179851529K123475SHOOCIN INTRODUCER KITDYB2014-02-03
1546831443827946K123473HOPER PTCA BALLOON CATHETERLOX2013-08-13
1546831419404098K123030COMPRESSOR NEBULIZER MODEL MCN-S600XXCAF2013-12-19
1546831754282578K121474DISPOSABLE LINEAR STAPLER, DISPOSABLE LINEAR CUTTERGDW2012-07-16
1546831477699587K120475ANESTHESIA CONDUCTION NEEDLESBSP2012-12-21
1546831689451744K120119SUNMED GUIDE WIREDQX2012-05-11
281911248168846K113468ELM PTA BALLON DILATATION CATHETERLIT2011-12-20
839352044718311K113468ELM PTA BALLON DILATATION CATHETERLIT2011-12-20
1546831183132224K112204
1546831539093019K112057KDL SYRINGES AND NEEDLEFMF2011-12-14
1546831271522406K111837RADIAL ARTERY COMPRESSION TOURNIQUETDXC2011-09-27
1546831473502596K111559SURGICAL MASKSFXX2011-09-16
1546831164349444K110853VR MEDICAL ENTERAL ORAL SYRINGEFPD2011-05-13
1546831508611908K110421DISPOSABLE INSULIN SYRINGEFMF2011-04-26
1546831712040921K110269WELL LEAD ENDOTRACHEAL TUBE WITH EVACUATION LUMEN-ORALBTR2011-08-26
1546831583438641K110182CANNABINOIDS URINE TESTLDJ2011-05-20
1546832022199172K102898BELLOTA SONOHYSTEROGRAPHY CATHETER WITH CERVICAL CONE, BELLOTA SONOHYSTEROGRAPHY CATHETER WITHOUT CERVICAL CONELKF2011-12-15
1546831851985413K102833DISPOSABLE HEMODIALYSIS ACCESS CATHETER SETSMPB2011-11-18
1546832005629314K102372OBS DISPOSABLE ELECTROSURGICAL PADS, MONOPOLAR, BIOPOLAR, MODELS GBS-DM, GBS-DBGEI2010-11-03
1546831028118991K102316GLUCOSE SHEPHERD BLOOD GLUCOSE MONITORING SYSTEMCGA2011-10-07
839351802528173K102211CRUISER 18 GUIDEWIREDQX2010-09-03
1546831765517944K101136FISIO CHAMBER SPACENVP2011-01-28
839351828161358K100799FORTRESS INTRODUCER SHEATH SYSTEM MODEL 358813, 358814, 358815DYB2011-02-25
1546831288749777K100723DISPOSABLE CIRCULAR STAPLER, DISPOSABLE CIRCULAR STAPLER MODEL KYGW-25.5, KYGW-28.5GDW2010-04-30
1546831840105434K093910IMPROVACUTER GEL & CLOT ACTIVATOR TUBEJKA2010-07-12
1546831135152512K092984PANPAC UTERINE INECTOR, MODEL UI-4.0, UI-2.0LKF2010-04-07
1546831005158084K092983PANPAC HSG CATHETER SETLKF2010-06-07
1546831575959213K092982THE PANPAC SUCTION CURETTEHHK2010-07-26
1546831034958984K092981PANPAC VAGINAL PESSARYHHW2010-07-22
1546831787975014K092980PANPAC UTERINE MANIPULATOR INJECTOR, MODEL UMI 4.5LKF2010-03-11
1546831852657256K092886WELL LEAD ENDOBRONCHIAL TUBESCBI2010-03-11
1546831333611939K092634OBS DISPOSABLE ELECTROSURGICAL PENCILS, MODELS: OBS-DB, OBS-DR, OBS-DFGEI2009-12-01
1546832024517951K091516WELL LEAD SILICONE CATHETER WITH TEMPERATURE SENSOREZL2009-10-16
839351961452980K090193CONDUCTOR CORONARY GUIDEWIREDQX2009-09-25
1546831679473402K083687BAIXIN INTRAVASCULAR ADMINISTRATION SETFPA2009-06-11
281911467190724K083674PK-141 PATIENT CABLEDTC2009-04-01
1546831704221166K083429I.V. CATHETER, MODELS: TYPE I, TYPE Y, TYPE STRAIGHTFOZ2009-08-07
281911277664842K083094STREAMER POLYMER GUIDEWIREDQX2009-07-07
281911084472692K082935VISION WIRE CORONARY GUIDEWIREDQX2008-12-04
839352072213833K082933PASSEO-35 PTA CATHETERDQY2008-11-03
1546831650705880K082815WELL LEAD SILICONE AND LATEX FOLEY CATHETERSEZL2008-10-08
1546831388901649K082439DISPOSABLE ANGIOGRAPHIC SYRINGE, MODEL(S) CT-200-NE, CT-200-MA, CT-200+200-MA, CT-200-LF, CT -100-NE, CT-200NE, CT-50+CTDXT2009-03-23
1546831433362342K080684WG-SURGICAL SUTURES WITH NEEDLEGAP2008-06-09
1546831224813831K073614WG-SURGICAL SUTURES WITH NEEDLENEW2008-04-30
1546831403416607K073383WELL LEAD REINFORCED ENDOTRACHEAL TUBEBTR2008-07-10
1546831602669815K073127BLOOD COLLECTION NEEDLE, MODEL 20G 21G 22GFMI2007-12-20
839351317498973K072765PASSEO 18LIT2007-12-12
1546832050489939K072739JIERUI SYRINGES AND NEEDLESMEG2008-03-21

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
LIT82025-04-04
DQY72024-09-12
DQX72012-05-11
MXD62023-05-19
FMI62022-11-04
JKA52023-03-24
FOZ52020-04-23
LKF42011-12-15
MEG32021-10-18
EZL32020-12-15
LOX32017-01-26
DYB32016-01-11
GAM32014-01-14
GDW32013-07-05
FMF32011-12-14
BTR32011-08-26
DTD32001-01-18
FMK22022-10-28
DRF22021-10-15
NIQ22019-02-22
FXX22016-06-15
CAF22015-01-08
GEI22010-11-03
GAP22008-06-09
NEW22008-04-30
MRM22006-08-10
LCX22006-07-18
KGO22003-10-17
LYY22002-01-17
LLZ12024-04-24
DRB12019-08-01
FYA12019-01-16
PIF12018-07-12
NIP12017-03-23
MAF12017-02-14
PNR12016-09-22
NIO12015-12-17
DQO12015-03-20
MAV12014-12-12
CAH12014-07-30

PMA#

Protego EP PASSION

2023-01-16

BIOTRONIK, INC.6024 Jean Roadlake Oswego, OR 97035 PMA NumberP050023 Supplement NumberS170 Date Received11/30/2022 Decision Date01/16/2023 Product Code MRM  Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track No User Fee Supplement Reason ...

Protego EP PASSION

2023-01-16

BIOTRONIK, INC.6024 Jean Roadlake Oswego, OR 97035 PMA NumberP980023 Supplement NumberS118 Date Received11/30/2022 Decision Date01/16/2023 Product Code LWS  Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track No User Fee Supplement Reason ...

Pacemaker/ICD/CRT Non-Implanted Components PSW 2202.U and NEO 2202.U

2023-01-12

BIOTRONIK, INC.6024 Jean Roadlake Oswego, OR 97035 PMA NumberP070008 Supplement NumberS143 Date Received11/15/2022 Decision Date01/12/2023 Product Code NKE  Advisory Committee Cardiovascular Supplement Typereal-time Process Supplement Reason Change Design/c...

Pacemaker/ICD/CRT Non-Implanted Components PSW 2202.U and NEO 2202.U

2023-01-12

BIOTRONIK, INC.6024 Jean Roadlake Oswego, OR 97035 PMA NumberP050023 Supplement NumberS169 Date Received11/15/2022 Decision Date01/12/2023 Product Code MRM  Advisory Committee Cardiovascular Supplement Typereal-time Process Supplement Reason Change Design/c...

Pacemaker/ICD/CRT Non-Implanted Components PSW 2202.U and NEO 2202.U

2023-01-12

BIOTRONIK, INC.6024 Jean Roadlake Oswego, OR 97035 PMA NumberP000009 Supplement NumberS100 Date Received11/15/2022 Decision Date01/12/2023 Product Code MRM  Advisory Committee Cardiovascular Supplement Typereal-time Process Supplement Reason Change Design/c...

Drug-Eluting Permanent Defibrillator Electrodes

2022-12-16

BIOTRONIK, INC.6024 Jean Roadlake Oswego, OR 97035 PMA NumberP980023 Supplement NumberS117 Date Received11/23/2022 Decision Date12/16/2022 Product Code LWS  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Ma...

Pulse Generator, Permanent, Implantable

2022-12-07

BIOTRONIK, INC.6024 Jean Roadlake Oswego, OR 97035 PMA NumberP950037 Supplement NumberS241 Date Received11/10/2022 Decision Date12/07/2022 Product Code DXY  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Ma...

Implantable Cardioverter Defibrillator (Non-CRT)

2022-12-07

BIOTRONIK, INC.6024 Jean Roadlake Oswego, OR 97035 PMA NumberP980023 Supplement NumberS116 Date Received11/10/2022 Decision Date12/07/2022 Product Code LWS  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Ma...

Defibrillator, implantable, dual-chamber

2022-12-07

BIOTRONIK, INC.6024 Jean Roadlake Oswego, OR 97035 PMA NumberP000009 Supplement NumberS099 Date Received11/10/2022 Decision Date12/07/2022 Product Code MRM  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Ma...

DataBridge 4G/LTE Adapter

2022-12-02

BIOTRONIK, INC.6024 Jean Roadlake Oswego, OR 97035 PMA NumberP950037 Supplement NumberS240 Date Received09/26/2022 Decision Date12/02/2022 Product Code DXY  Advisory Committee Cardiovascular Supplement Typereal-time Process Supplement Reason Change Design/c...

Drug Eluting Permanent Left Ventricular (LV) Pacemaker Electrode

2022-11-16

BIOTRONIK, INC.6024 Jean Roadlake Oswego, OR 97035 PMA NumberP070008 Supplement NumberS141 Date Received10/18/2022 Decision Date11/16/2022 Product Code NKE  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Ma...

Drug Eluting Permanent Left Ventricular (LV) Pacemaker Electrode

2022-10-20

BIOTRONIK, INC.6024 Jean Roadlake Oswego, OR 97035 PMA NumberP070008 Supplement NumberS140 Date Received09/22/2022 Decision Date10/20/2022 Product Code NKE  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Ma...

Permanent Defibrillator Electrodes

2022-10-20

BIOTRONIK, INC.6024 Jean Roadlake Oswego, OR 97035 PMA NumberP980023 Supplement NumberS115 Date Received09/22/2022 Decision Date10/20/2022 Product Code LWS  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Ma...

Pulse Generator, Permanent, Implantable

2022-09-15

BIOTRONIK, INC.6024 Jean Roadlake Oswego, OR 97035 PMA NumberP950037 Supplement NumberS238 Date Received08/29/2022 Decision Date09/15/2022 Product Code DXY  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Ma...

Astron Pulsar Stent System, Pulsar-18 Stent System

2022-07-27

BIOTRONIK, INC.6024 Jean Roadlake Oswego, OR 97035 PMA NumberP160025 Supplement NumberS015 Date Received06/21/2022 Decision Date07/27/2022 Product Code NIP  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Ma...

PRO-Kinetic Energy Coronary Stent System

2022-07-27

BIOTRONIK, INC.6024 Jean Roadlake Oswego, OR 97035 PMA NumberP160003 Supplement NumberS015 Date Received06/21/2022 Decision Date07/27/2022 Product Code MAF  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Ma...

Astron Peripheral Self-Expanding Nitinol Stent System

2022-07-27

BIOTRONIK, INC.6024 Jean Roadlake Oswego, OR 97035 PMA NumberP140030 Supplement NumberS015 Date Received06/21/2022 Decision Date07/27/2022 Product Code NIO  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Ma...

Pulse Generator, Permanent, Implantable

2022-06-21

BIOTRONIK, INC.6024 Jean Roadlake Oswego, OR 97035 PMA NumberP950037 Supplement NumberS236 Date Received06/17/2022 Decision Date06/21/2022 Product Code DXY  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Ma...

Implantable Cardioverter Defibrillator (Non-CRT)

2022-06-21

BIOTRONIK, INC.6024 Jean Roadlake Oswego, OR 97035 PMA NumberP980023 Supplement NumberS114 Date Received06/17/2022 Decision Date06/21/2022 Product Code LWS  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Ma...

Defibrillator, Implantable, dual-chamber

2022-06-21

BIOTRONIK, INC.6024 Jean Roadlake Oswego, OR 97035 PMA NumberP000009 Supplement NumberS098 Date Received06/17/2022 Decision Date06/21/2022 Product Code MRM  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Ma...

Pulsar-18 Stent Systems

2022-05-20

BIOTRONIK, INC.6024 Jean Roadlake Oswego, OR 97035 PMA NumberP160025 Supplement NumberS014 Date Received04/20/2022 Decision Date05/20/2022 Product Code NIP  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Ma...

PSW 2201.U/1 and NEO 2201.U/1

2022-04-11

BIOTRONIK, INC.6024 Jean Roadlake Oswego, OR 97035 PMA NumberP070008 Supplement NumberS136 Date Received02/07/2022 Decision Date04/11/2022 Product Code NKE  Advisory Committee Cardiovascular Supplement Typereal-time Process Supplement Reason Change Design/c...

PSW 2201.U/1 and NEO 2201.U/1

2022-04-11

BIOTRONIK, INC.6024 Jean Roadlake Oswego, OR 97035 PMA NumberP050023 Supplement NumberS166 Date Received02/07/2022 Decision Date04/11/2022 Product Code MRM  Advisory Committee Cardiovascular Supplement Typereal-time Process Supplement Reason Change Design/c...

PSW 2201.U/1 and NEO 2201.U/1

2022-04-11

BIOTRONIK, INC.6024 Jean Roadlake Oswego, OR 97035 PMA NumberP000009 Supplement NumberS097 Date Received02/07/2022 Decision Date04/11/2022 Product Code MRM  Advisory Committee Cardiovascular Supplement Typereal-time Process Supplement Reason Change Design/c...

Drug-Eluting Permanent Defibrillator Electrodes

2022-03-15

BIOTRONIK, INC.6024 Jean Roadlake Oswego, OR 97035 PMA NumberP980023 Supplement NumberS112 Date Received02/17/2022 Decision Date03/15/2022 Product Code LWS  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Ma...

200 records. Showing 1-40. Next

PMN#

156 records. Showing 1-40. Next

GUDID#

80 records. Showing 1-40. Next