FDA.reportPublic FDA data

Boston-Scientific-Corp

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
12256873001451463Boston Scientific Corp., Marina Bay Cust. Fulfillment Center1Y2026-01-01500 Commander Shea Boulevard QUINCY MA US 02171
18281321828132BOSTON SCIENTIFIC CORPORATION1N2026-01-01780 BROOKSIDE DRIVE SPENCER IN US 47460
21242152124215Boston Scientific Corporation1Y2026-01-014100 Hamline Ave N Saint Paul MN US 55112
21342653002095335BOSTON SCIENTIFIC CORPORATION1Y2026-01-01Two Scimed Place Maple Grove MN US 55311
26487292648729Boston Scientific Corporation1N2026-01-01No. 12, RD. No. 698 Dorado PR US 00646
10001210561000121056Boston Scientific Corporation1N2026-01-018 Industrial Dr Coventry RI US 02816
30050998033005099803BOSTON SCIENTIFIC CORPORATION1N2026-01-01100 BOSTON SCIENTIFIC WAY Marlborough MA US 01752
30056198803005619880Boston Scientific Corporation1N2026-01-011100 Old Ellis Rd Suite 1200 Roswell GA US 30076
30076959593007695959Boston Scientific Corporation1N2026-01-012546 First Street, Propark El Coyol Alajuela CR 20904
30107057683010705768Boston Scientific Corporation1N2026-01-01309 Waverley Oaks Rd. Waltham MA US 02452
30253414843025341484BOSTON SCIENTIFIC CORPORATION1N2026-01-01Zona Franca La Lima Cartago CR 30106
30273457943027345794Boston Scientific Corporation1Y2026-01-0110700 Xylon Av N Brooklyn Park MN US 55445
30325077963032507796BOSTON SCIENTIFIC CORPORATION1Y2026-01-0111480 Lakefield Drive Johns Creek GA US 30097
29392042939204Boston Scientific Corporation1N2020-04-2547215 Lakeview Boulevard FREMONT CA US 94538
30012363493001236349Boston Scientific Corporation1Y2020-04-25150 Baytech Drive San Jose CA US 95134
30038827833003882783BOSTON SCIENTIFIC CORPORATION1N2020-04-25160 KNOWLES DRIVE LOS GATOS CA US 95032
30101783263010178326Boston Scientific Corporation1N2020-04-251745 Copperhill Pkwy Santa Rosa CA US 95403

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
267561511121162P980037ANGIOJET RHEOLYTIC THROMBECTOMY LF140 CATHETERMCX1999-03-12
267621511121162P980037ANGIOJET RHEOLYTIC THROMBECTOMY LF140 CATHETERMCX1999-03-12
689131511121162P980037ANGIOJET RHEOLYTIC THROMBECTOMY LF140 CATHETERMCX1999-03-12
771901511121162P980037ANGIOJET RHEOLYTIC THROMBECTOMY LF140 CATHETERMCX1999-03-12
1221951511121162P980037ANGIOJET RHEOLYTIC THROMBECTOMY LF140 CATHETERMCX1999-03-12
1222011511121162P980037ANGIOJET RHEOLYTIC THROMBECTOMY LF140 CATHETERMCX1999-03-12
1756291511121162P980037ANGIOJET RHEOLYTIC THROMBECTOMY LF140 CATHETERMCX1999-03-12
1221951517525685P980033WALLSTENT ENDOPROSTHESISQKJ2001-11-16
1756291517525685P980033WALLSTENT ENDOPROSTHESISQKJ2001-11-16
771901607541825P980003CHILLI COOLED RF ABLATION SYSTEMLPB1999-02-02
1221951607541825P980003CHILLI COOLED RF ABLATION SYSTEMLPB1999-02-02
1221951261241681P960040VENTAK AV AICD VENTAK PRIZM DR/VR, VITALITY, COFIENT, AND TELIGEN AUTOMATIC IMPLANTABLE CARDIOVETER DEFIBRILLATOR SYSTEMLWS1997-07-18
1221951716593902P960006SWEET TIP(R) RX STEROID ELUTING LEADNVN1998-10-02
1222011716593902P960006SWEET TIP(R) RX STEROID ELUTING LEADNVN1998-10-02
1221951545046432P960004THINLINE ENDOCARDIAL PACING LEADSNVN1996-11-12
1222011545046432P960004THINLINE ENDOCARDIAL PACING LEADSNVN1996-11-12
689131352338383P950020FLEXATOME CUTTING BALLOONNWX2000-04-18
1221951352338383P950020FLEXATOME CUTTING BALLOONNWX2000-04-18
1756291352338383P950020FLEXATOME CUTTING BALLOONNWX2000-04-18
1221951747021444P940019WALLSTENT(R) ILIAC ENDOPROSTHESISNIO1996-05-28
1756291747021444P940019WALLSTENT(R) ILIAC ENDOPROSTHESISNIO1996-05-28
1221951465109137P930035VENTAK(R) P2 SYSTEMLWS1995-03-10
1221951419367627P930031WALLSTENT(R) TIPS ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEMMIR1995-09-29
1756291419367627P930031WALLSTENT(R) TIPS ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEMMIR1995-09-29
1036181923360514P920047EPT-1000 CARDIAC ABLATION SYSTEMLPB1994-10-28
1221951923360514P920047EPT-1000 CARDIAC ABLATION SYSTEMLPB1994-10-28
1756291923360514P920047EPT-1000 CARDIAC ABLATION SYSTEMLPB1994-10-28
1221952072263923P910077VENTAK(R) PRX (TM) MODEL 1700,1705 PULSE GENERATORLWS1994-06-17
267621708953900P910073ENDOTAK LEAD SYSTEMLWS1993-08-26
1221951708953900P910073ENDOTAK LEAD SYSTEMLWS1993-08-26
1222011708953900P910073ENDOTAK LEAD SYSTEMLWS1993-08-26
1756291708953900P910073ENDOTAK LEAD SYSTEMLWS1993-08-26
267561042955031P900056ROTABLATOR(R)MCX1993-05-28
267621042955031P900056ROTABLATOR(R)MCX1993-05-28
689131042955031P900056ROTABLATOR(R)MCX1993-05-28
771901042955031P900056ROTABLATOR(R)MCX1993-05-28
1036181042955031P900056ROTABLATOR(R)MCX1993-05-28
1221951042955031P900056ROTABLATOR(R)MCX1993-05-28
1756291042955031P900056ROTABLATOR(R)MCX1993-05-28
267621361749618P860019SCIMED PTCA DILATATION CATHETERLOX1986-11-28
689131361749618P860019SCIMED PTCA DILATATION CATHETERLOX1986-11-28
1221951361749618P860019SCIMED PTCA DILATATION CATHETERLOX1986-11-28
1221951933696276P830060VENTAK AND AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (AICD) SYSTEMSLWS1985-10-04
267621291648365P230035AGENT Paclitaxel-Coated Balloon CatheterOOB2024-02-29
689131291648365P230035AGENT Paclitaxel-Coated Balloon CatheterOOB2024-02-29
1221951291648365P230035AGENT Paclitaxel-Coated Balloon CatheterOOB2024-02-29
1221951515190534P230030FARAPULSE™ Pulsed Field Ablation System (FARAWAVE™ Pulsed Field Ablation Catheter, FARASTAR™ Catheter Connection Cable,QZI2024-01-30
1756291515190534P230030FARAPULSE™ Pulsed Field Ablation System (FARAWAVE™ Pulsed Field Ablation Catheter, FARASTAR™ Catheter Connection Cable,QZI2024-01-30
1221951382237580P220032POLARx/POLARx FIT Cryoablation Catheters, SMARTFREEZE Cryoablation Console, AccessoriesOAE2023-08-08
1756291382237580P220032POLARx/POLARx FIT Cryoablation Catheters, SMARTFREEZE Cryoablation Console, AccessoriesOAE2023-08-08
689131414172803P200029TheraSphereNAW2021-03-17
1221951414172803P200029TheraSphereNAW2021-03-17
267621580189764P190019Ranger™ Paclitaxel-Coated PTA Balloon CatheterONU2020-10-30
689131580189764P190019Ranger™ Paclitaxel-Coated PTA Balloon CatheterONU2020-10-30
1221951580189764P190019Ranger™ Paclitaxel-Coated PTA Balloon CatheterONU2020-10-30
1756291580189764P190019Ranger™ Paclitaxel-Coated PTA Balloon CatheterONU2020-10-30
1221951888768123P190006Axonics Sacral Neuromodulation SystemQON2019-09-06
1221951332365242P180046Axonics Sacral Neuromodulation SystemEZW2019-11-13
267621219392652P180029LOTUS Edge Valve SystemNPT2019-04-23
689161219392652P180029LOTUS Edge Valve SystemNPT2019-04-23
267621040963809P180011Eluvia Drug-Eluting Vascular Stent SystemNIU2018-09-18
689131040963809P180011Eluvia Drug-Eluting Vascular Stent SystemNIU2018-09-18
1221951040963809P180011Eluvia Drug-Eluting Vascular Stent SystemNIU2018-09-18
1756291040963809P180011Eluvia Drug-Eluting Vascular Stent SystemNIU2018-09-18
1221951712452773P170023Bulkamid Urethral Bulking SystemLNM2020-01-28
1221951401702589P150031VERCISE DEEP BRAIN STIMULATION (DBS)SYSTEMNHL2017-12-08
1222011401702589P150031VERCISE DEEP BRAIN STIMULATION (DBS)SYSTEMNHL2017-12-08
1221951201497276P150012IMAGEREADY MR CONDITIONAL PACING SYSTEM AND INGEVITY PACE/SENSE LEADLWP2016-04-25
1222011201497276P150012IMAGEREADY MR CONDITIONAL PACING SYSTEM AND INGEVITY PACE/SENSE LEADLWP2016-04-25
771901846987198P150005BLAZER OPEN-IRRIGATED ABLATION CATHETEROAD2016-02-24
1221951846987198P150005BLAZER OPEN-IRRIGATED ABLATION CATHETEROAD2016-02-24
1756291846987198P150005BLAZER OPEN-IRRIGATED ABLATION CATHETEROAD2016-02-24
1783981846987198P150005BLAZER OPEN-IRRIGATED ABLATION CATHETEROAD2016-02-24
267621719286576P150003SYNERGY EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEMNIQ2015-10-02
689131719286576P150003SYNERGY EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEMNIQ2015-10-02
1221951719286576P150003SYNERGY EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEMNIQ2015-10-02
1756291719286576P150003SYNERGY EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEMNIQ2015-10-02
267621833215550P140028INNOVA VASCULAR SELF-EXPANDING STENT WITH DELIVERY SYSTEMNIP2015-07-21
689131833215550P140028INNOVA VASCULAR SELF-EXPANDING STENT WITH DELIVERY SYSTEMNIP2015-07-21
1221951833215550P140028INNOVA VASCULAR SELF-EXPANDING STENT WITH DELIVERY SYSTEMNIP2015-07-21
1756291833215550P140028INNOVA VASCULAR SELF-EXPANDING STENT WITH DELIVERY SYSTEMNIP2015-07-21
1221951674222266P140026ENROUTE TRANSCAROTID STENT SYSTEMNIM2015-05-18
267391480290140P140008ORBERA INTRAGASTRIC BALLOONLTI2015-08-05
1036181480290140P140008ORBERA INTRAGASTRIC BALLOONLTI2015-08-05
267621649464100P130030REBEL PLATINUM CHROMIUM CORONARY STENT SYSTEM MONORAIL AND OVER THE WIREMAF2026-03-10
689131649464100P130030REBEL PLATINUM CHROMIUM CORONARY STENT SYSTEM MONORAIL AND OVER THE WIREMAF2026-03-10
1221951649464100P130030REBEL PLATINUM CHROMIUM CORONARY STENT SYSTEM MONORAIL AND OVER THE WIREMAF2026-03-10
1756291649464100P130030REBEL PLATINUM CHROMIUM CORONARY STENT SYSTEM MONORAIL AND OVER THE WIREMAF2026-03-10
267621951386063P130013WATCHMAN LEFT ATRIAL APPENDAGE (LAA) CLOSURE TECHNOLOGYNGV2015-03-13
689131951386063P130013WATCHMAN LEFT ATRIAL APPENDAGE (LAA) CLOSURE TECHNOLOGYNGV2015-03-13
1221951951386063P130013WATCHMAN LEFT ATRIAL APPENDAGE (LAA) CLOSURE TECHNOLOGYNGV2015-03-13
1756291951386063P130013WATCHMAN LEFT ATRIAL APPENDAGE (LAA) CLOSURE TECHNOLOGYNGV2015-03-13
267441740614124P110042SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEMLWS2012-09-28
1221951740614124P110042SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEMLWS2012-09-28
1222011740614124P110042SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEMLWS2012-09-28
267621310175420P110035EPIC SELF-EXPANDING NITINOL STENT SYSTEMNIO2012-04-13
1221951310175420P110035EPIC SELF-EXPANDING NITINOL STENT SYSTEMNIO2012-04-13
1756291310175420P110035EPIC SELF-EXPANDING NITINOL STENT SYSTEMNIO2012-04-13
267621144344264P110010PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEMNIQ2011-11-22
1221951144344264P110010PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEMNIQ2011-11-22
1756291144344264P110010PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEMNIQ2011-11-22
1221951325594545P090003EXPRESS LD ILIAC PREMOUNTED STENT SYSTEMNIO2010-03-05
267391645200515P080032ALAIR BRONCHIAL THERMOPLASTY SYSTEMOOY2010-04-27
267621645200515P080032ALAIR BRONCHIAL THERMOPLASTY SYSTEMOOY2010-04-27
689131384799466P060006BOSTON SCIENTIFIC EXPRESS SD RENAL MONORAIL PREMOUNTED STENT SYSTEMNIN2008-12-11
1221951384799466P060006BOSTON SCIENTIFIC EXPRESS SD RENAL MONORAIL PREMOUNTED STENT SYSTEMNIN2008-12-11
1756291384799466P060006BOSTON SCIENTIFIC EXPRESS SD RENAL MONORAIL PREMOUNTED STENT SYSTEMNIN2008-12-11
1221951326445800P050046ACUITY STEERABLE LEAD SYSTEMOJX2007-04-13
1222011326445800P050046ACUITY STEERABLE LEAD SYSTEMOJX2007-04-13
1221951357706852P050019CAROTID WALLSTENT MONORAIL ENDOPROSTHESISNIM2008-10-23
1221951259418821P030017PRECISION SPINAL CORD STIMULATION(SCS) SYSTEMLGW2004-04-27
1222011259418821P030017PRECISION SPINAL CORD STIMULATION(SCS) SYSTEMLGW2004-04-27
1221951069547642P030005CONTAK RENEWAL MODELS H125 AND H120 WITH THE MODEL 2865 VERSION 1.8 APPLICATION SOFTWARENKE2004-01-26
267561842603510P020025EP TECHNOLOGIES EPT-1000 XP RF ABLATION SYSTEMOAD2003-08-25
771901842603510P020025EP TECHNOLOGIES EPT-1000 XP RF ABLATION SYSTEMOAD2003-08-25
1036181842603510P020025EP TECHNOLOGIES EPT-1000 XP RF ABLATION SYSTEMOAD2003-08-25
1221951842603510P020025EP TECHNOLOGIES EPT-1000 XP RF ABLATION SYSTEMOAD2003-08-25
1756291842603510P020025EP TECHNOLOGIES EPT-1000 XP RF ABLATION SYSTEMOAD2003-08-25
1783981842603510P020025EP TECHNOLOGIES EPT-1000 XP RF ABLATION SYSTEMOAD2003-08-25
1221951452976857P010012CONTAK CD,EASYTRAK, LIVIAN, COGNIS AND ACUITY SPIRIAL AUTOMATIC IMPLANTABLE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLLNIK2002-05-02

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DQX792022-12-19
FGE762025-07-03
DQY532024-02-01
GEX462025-10-30
LOX412022-03-24
LIT402024-07-10
FAD392025-04-15
DQK352025-05-28
KNS352023-10-27
GEH342024-10-18
DRF332025-06-27
DYB302025-03-20
ODG282022-12-30
KRD272024-10-03
QEY252022-04-20
QEZ252012-06-06
FDI232020-10-08
QEW222024-05-29
OBJ212023-05-18
MCW182022-09-06
GEI182016-07-07
KRA172026-05-15
FGB172025-09-24
DQO172015-10-29
PKL162025-02-06
OTN162023-06-29
ODC152025-10-09
EOQ142023-03-02
MCX141999-03-12
KNT132021-04-27
ITX132020-04-17
FED122025-03-21
GXI122022-10-26
DXF112024-11-01
ESW112024-04-29
KOD112018-04-10
LWS112012-09-28
OVB102026-02-10
DRE102024-07-12
OCW102023-06-29

NDC#

Varithena

Boston Scientific Corporation

polidocanol

Varithena

Boston Scientific Corporation

polidocanol

PMA#

Rotablator and ROTAPRO Rotational Atherectomy System

2023-02-02

Boston Scientific Corp.two Scimed Placemaple Grove, MN 55311-1566 PMA NumberP900056 Supplement NumberS204 Date Received01/06/2023 Decision Date02/02/2023 Product Code MCX  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Proc...

WATCHMAN FLX™ Left Atrial Appendage Closure with Delivery System

2023-01-20

Boston Scientific Corp.one Scimed Placemaple Grove, MN 55311-1566 PMA NumberP130013 Supplement NumberS056 Date Received10/25/2022 Decision Date01/20/2023 Product Code NGV  Advisory Committee Cardiovascular Supplement Typereal-time Process Supplement Reason ...

WOLVERINE™ Coronary Cutting Balloon®

2023-01-18

Boston Scientific Corp.one Scimed Placemaple Grove, MN 55311-1566 PMA NumberP950020 Supplement NumberS134 Date Received01/10/2023 Decision Date01/18/2023 Product Code NWX  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Proc...

Vercise Deep Brain Stimulation (DBS) Systems

2023-01-06

Boston Scientific Corp.25155 Rye Canyon Loopvalencia, CA 91355 PMA NumberP150031 Supplement NumberS054 Date Received12/08/2022 Decision Date01/06/2023 Product Code NHL  Advisory Committee Neurology Supplement Type30-day Notice Supplement Reason Process Chan...

Precision Spinal Cord Stimulator (SCS) Systems

2023-01-06

Boston Scientific Corp.25155 Rye Canyon Loopvalencia, CA 91355 PMA NumberP030017 Supplement NumberS356 Date Received12/08/2022 Decision Date01/06/2023 Product Code LGW  Advisory Committee Neurology Supplement Type30-day Notice Supplement Reason Process Chan...

Vercise Deep Brain Stimulation (DBS) Systems

2022-12-17

Boston Scientific Corp.25155 Rye Canyon Loopvalencia, CA 91355 PMA NumberP150031 Supplement NumberS053 Date Received12/07/2022 Decision Date12/17/2022 Product Code NHL  Advisory Committee Neurology Supplement Type30-day Notice Supplement Reason Process Chan...

Precision Spinal Cord Stimulator (SCS) Systems

2022-12-17

Boston Scientific Corp.25155 Rye Canyon Loopvalencia, CA 91355 PMA NumberP030017 Supplement NumberS355 Date Received12/07/2022 Decision Date12/17/2022 Product Code LGW  Advisory Committee Neurology Supplement Type30-day Notice Supplement Reason Process Chan...

SICD Gen 2, SICD MRI

2022-12-14

BOSTON SCIENTIFIC CORPORATION4100 Hamline Avenue Northst. Paul, MN 55112-5798 PMA NumberP110042 Supplement NumberS177 Date Received12/07/2022 Decision Date12/14/2022 Product Codes NVY LWS  Advisory Committee Cardiovascular Supplement Type30-day Notice Suppl...

WOLVERINE™ Coronary Cutting Balloon®

2022-12-07

Boston Scientific Corp.one Scimed Placemaple Grove, MN 55311-1566 PMA NumberP950020 Supplement NumberS132 Date Received12/02/2022 Decision Date12/07/2022 Product Code NWX  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Proc...

TheraSphere

2022-12-02

Boston Scientific Corporation300 Boston Scientific Waymarlborough, MA 01752 PMA NumberP200029 Supplement NumberS004 Date Received11/02/2022 Decision Date12/02/2022 Product Code NAW  Advisory Committee Radiology Supplement Typenormal 180 Day Track No User Fe...

Express® LD Iliac Premounted Stent System

2022-11-28

BOSTON SCIENTIFIC CORPORATIONone Scimed Placemaple Grove, MN 55311 PMA NumberP090003 Supplement NumberS053 Date Received11/14/2022 Decision Date11/28/2022 Product Code NIO  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Pro...

Promus Everolimus-Eluting Platinum Chromium Coronary Stent Systems

2022-11-28

Boston Scientific Corp.one Scimed Placemaple Grove, MN 55311-1566 PMA NumberP110010 Supplement NumberS206 Date Received11/14/2022 Decision Date11/28/2022 Product Code NIQ  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Proc...

Carotid WALLSTENT™ Monorail Endoprosthesis System

2022-11-28

Boston Scientific Corp.three Scimed Placemaple Grove, MN 55311-1566 PMA NumberP050019 Supplement NumberS036 Date Received11/14/2022 Decision Date11/28/2022 Product Code NIM  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Pr...

Ranger-Over-The-Wire Paclitaxel Coated Balloon Catheter

2022-11-23

Boston Scientific Corporationthree Scimed Placemaple Grove, MN 55311-1566 PMA NumberP190019 Supplement NumberS017 Date Received11/03/2022 Decision Date11/23/2022 Product Code ONU  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Rea...

Vercise Deep Brain Stimulation (DBS) Systems

2022-11-22

Boston Scientific Corp.25155 Rye Canyon Loopvalencia, CA 91355 PMA NumberP150031 Supplement NumberS051 Date Received11/14/2022 Decision Date11/22/2022 Product Code NHL  Advisory Committee Neurology Supplement Type30-day Notice Supplement Reason Process Chan...

Precision Spinal Cord Stimulator (SCS) Systems

2022-11-22

Boston Scientific Corp.25155 Rye Canyon Loopvalencia, CA 91355 PMA NumberP030017 Supplement NumberS352 Date Received11/14/2022 Decision Date11/22/2022 Product Code LGW  Advisory Committee Neurology Supplement Type30-day Notice Supplement Reason Process Chan...

Open-Irrigated Cardiac Ablation Catheters

2022-11-21

Boston Scientific Corp.150 Baytech Drivesan Jose, CA 95134 PMA NumberP150005 Supplement NumberS072 Date Received08/26/2022 Decision Date11/21/2022 Product Code OAD  Advisory Committee Cardiovascular Supplement Typereal-time Process Supplement Reason Change ...

WOLVERINE Coronary Cutting Balloon

2022-11-17

Boston Scientific Corp.one Scimed Placemaple Grove, MN 55311-1566 PMA NumberP950020 Supplement NumberS131 Date Received11/15/2022 Decision Date11/17/2022 Product Code NWX  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Proc...

Blazer II Cardiac Ablation System and Cable

2022-11-15

Boston Scientific Corp.150 Baytech Drivesan Jose, CA 95134 PMA NumberP920047 Supplement NumberS129 Date Received10/17/2022 Decision Date11/15/2022 Product Code LPB  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Cha...

Chilli Cooled RF Ablation System

2022-11-15

Boston Scientific Corp.150 Baytech Drivesan Jose, CA 95134 PMA NumberP980003 Supplement NumberS094 Date Received10/17/2022 Decision Date11/15/2022 Product Code LPB  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Cha...

Rotablator Rotational Atherectomy System

2022-11-15

Boston Scientific Corp.two Scimed Placemaple Grove, MN 55311-1566 PMA NumberP900056 Supplement NumberS203 Date Received10/17/2022 Decision Date11/15/2022 Product Code MCX  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Proc...

Ranger Paclitaxel-Coated PTA Balloon Catheter

2022-11-15

Boston Scientific Corporationthree Scimed Placemaple Grove, MN 55311-1566 PMA NumberP190019 Supplement NumberS016 Date Received10/17/2022 Decision Date11/15/2022 Product Code ONU  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Rea...

Blazer Open-Irrigated Ablation Catheter

2022-11-15

Boston Scientific Corp.150 Baytech Drivesan Jose, CA 95134 PMA NumberP150005 Supplement NumberS073 Date Received10/17/2022 Decision Date11/15/2022 Product Code OAD  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Cha...

Express® SD Renal Monorail Premounted Stent System

2022-11-15

Boston Scientific Corp.one Scimed Placemaple Grove, MN 55311-1566 PMA NumberP060006 Supplement NumberS104 Date Received10/17/2022 Decision Date11/15/2022 Product Code NIN  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Proc...

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PMN#

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GUDID#

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