FDA.report

Boston Scientific Corp., Marina Bay Cust. Fulfillment Center

Matched from indexed company URL: Boston Scientific

FDA Registration(s)

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
96812603002806565Boston Scientific Limited1N2026-01-01BALLYBRIT BUSINESS PARK GALWAY IE --
10001210561000121056Boston Scientific Corporation1N2026-01-018 Industrial Dr Coventry RI US 02816
30050998033005099803BOSTON SCIENTIFIC CORPORATION1N2026-01-01100 BOSTON SCIENTIFIC WAY Marlborough MA US 01752
30051113823005111382Boston Scientific International BV, European Dist. Ctr.1N2026-01-01VERSTASTRAAT 6 KERKRADE Limburg NL 6468 EX
30056198803005619880Boston Scientific Corporation1N2026-01-011100 Old Ellis Rd Suite 1200 Roswell GA US 30076
30066301503006630150Boston Scientific Neuromodulation Corporation1N2026-01-0125155 Rye Canyon Loop Valencia CA US 91355
30076959593007695959Boston Scientific Corporation1N2026-01-012546 First Street, Propark El Coyol Alajuela CR 20904
30098834023009883402Boston Scientific Cardiac Diagnostic Technologies, Inc.1N2026-01-012900 37th Street NW, Building 003 ROCHESTER MN US 55901
30107057683010705768Boston Scientific Corporation1N2026-01-01309 Waverley Oaks Rd. Waltham MA US 02452
30222985793022298579Boston Scientific Cardiac Diagnostic Technologies, Inc.1N2026-01-011150 Cummings Park Drive Arden Hills MN US 55112
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 keyListing keyPremarket submissionDeviceProduct codeDecision date
267561511121162P980037ANGIOJET RHEOLYTIC THROMBECTOMY LF140 CATHETERMCX1999-03-12
267581511121162P980037ANGIOJET 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
267381517525685P980033WALLSTENT ENDOPROSTHESISQKJ2001-11-16
267581517525685P980033WALLSTENT ENDOPROSTHESISQKJ2001-11-16
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
267581352338383P950020FLEXATOME CUTTING BALLOONNWX2000-04-18
689131352338383P950020FLEXATOME CUTTING BALLOONNWX2000-04-18
1221951352338383P950020FLEXATOME CUTTING BALLOONNWX2000-04-18
1756291352338383P950020FLEXATOME CUTTING BALLOONNWX2000-04-18
267381747021444P940019WALLSTENT(R) ILIAC ENDOPROSTHESISNIO1996-05-28
267581747021444P940019WALLSTENT(R) ILIAC ENDOPROSTHESISNIO1996-05-28
1221951747021444P940019WALLSTENT(R) ILIAC ENDOPROSTHESISNIO1996-05-28
1756291747021444P940019WALLSTENT(R) ILIAC ENDOPROSTHESISNIO1996-05-28
1221951465109137P930035VENTAK(R) P2 SYSTEMLWS1995-03-10
267381419367627P930031WALLSTENT(R) TIPS ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEMMIR1995-09-29
267581419367627P930031WALLSTENT(R) TIPS ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEMMIR1995-09-29
1221951419367627P930031WALLSTENT(R) TIPS ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEMMIR1995-09-29
1756291419367627P930031WALLSTENT(R) TIPS ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEMMIR1995-09-29
267581923360514P920047EPT-1000 CARDIAC ABLATION SYSTEMLPB1994-10-28
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
267581291648365P230035AGENT Paclitaxel-Coated Balloon CatheterOOB2024-02-29
267621291648365P230035AGENT Paclitaxel-Coated Balloon CatheterOOB2024-02-29
689131291648365P230035AGENT Paclitaxel-Coated Balloon CatheterOOB2024-02-29
1221951291648365P230035AGENT Paclitaxel-Coated Balloon CatheterOOB2024-02-29
267581515190534P230030FARAPULSE™ Pulsed Field Ablation System (FARAWAVE™ Pulsed Field Ablation Catheter, FARASTAR™ Catheter Connection Cable,QZI2024-01-30
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
267581382237580P220032POLARx/POLARx FIT Cryoablation Catheters, SMARTFREEZE Cryoablation Console, AccessoriesOAE2023-08-08
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
267381580189764P190019Ranger™ Paclitaxel-Coated PTA Balloon CatheterONU2020-10-30
267581580189764P190019Ranger™ Paclitaxel-Coated PTA Balloon CatheterONU2020-10-30
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
267581219392652P180029LOTUS Edge Valve SystemNPT2019-04-23
267621219392652P180029LOTUS Edge Valve SystemNPT2019-04-23
689161219392652P180029LOTUS Edge Valve SystemNPT2019-04-23
267581040963809P180011Eluvia Drug-Eluting Vascular Stent SystemNIU2018-09-18
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
786741401702589P150031VERCISE DEEP BRAIN STIMULATION (DBS)SYSTEMNHL2017-12-08
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
267581846987198P150005BLAZER OPEN-IRRIGATED ABLATION CATHETEROAD2016-02-24
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
267581719286576P150003SYNERGY EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEMNIQ2015-10-02
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
267581833215550P140028INNOVA VASCULAR SELF-EXPANDING STENT WITH DELIVERY SYSTEMNIP2015-07-21
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
786741730363118P140004SUPERION INTERSPINOUS SPACERNQO2015-05-20
267581649464100P130030REBEL PLATINUM CHROMIUM CORONARY STENT SYSTEM MONORAIL AND OVER THE WIREMAF2026-03-10
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
267581951386063P130013WATCHMAN LEFT ATRIAL APPENDAGE (LAA) CLOSURE TECHNOLOGYNGV2015-03-13
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
267581310175420P110035EPIC SELF-EXPANDING NITINOL STENT SYSTEMNIO2012-04-13
267621310175420P110035EPIC SELF-EXPANDING NITINOL STENT SYSTEMNIO2012-04-13

Product Codes Associated With Registrations

Product codeRegistration listing recordsLatest decision
FGE1052025-07-03
DQX1022022-12-19
DQY672024-02-01
LIT562024-07-10
LOX512022-03-24
GEX492025-10-30
FAD442025-04-15
KNS442023-10-27
DRF422025-06-27
DQK352025-05-28
ODG352022-12-30
GEH342024-10-18
KRD332024-10-03
DYB322025-03-20
QEZ302012-06-06
FDI292020-10-08
QEY282022-04-20
QEW262024-05-29
KRA222026-05-15
DQO222015-10-29
OBJ212023-05-18
GEI212016-07-07
ODC202025-10-09
PKL202025-02-06
OTN202023-06-29
GXI202022-10-26
FGB182025-09-24
MCW182022-09-06
ESW172024-04-29
EOQ172023-03-02
JCT152023-07-14
KNT152021-04-27
MCX151999-03-12
FED142025-03-21
OCW132023-06-29
ITX132020-04-17
KOD132018-04-10
EZN132013-05-22
LQR122021-05-26
OAD122016-02-24

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...

RELIANCE 4-FRONT

2023-01-16

BOSTON SCIENTIFIC4100 Hamline Avenue Northst. Paul, MN 55112 PMA NumberP910073 Supplement NumberS171 Date Received01/05/2023 Decision Date01/16/2023 Product Code LWS  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process C...

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...

Superion Indirect Decompression System

2023-01-06

Boston Scientific Neuromodulation25155 Rye Canyon Loopvalencia, CA 91355 PMA NumberP140004 Supplement NumberS029 Date Received12/08/2022 Decision Date01/06/2023 Product Code NQO  Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason P...

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...

LATITUDE Wave Communicator Model 6290

2022-12-14

BOSTON SCIENTIFIC4100 Hamline Avenue Northst. Paul, MN 55112 PMA NumberP910077 Supplement NumberS190 Date Received11/16/2022 Decision Date12/14/2022 Product Code LWS  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process C...

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...

WALLSTENT™ ILIAC RP Endoprosthesis

2022-11-28

BOSTON SCIENTIFIC SCIMED, INC.one Scimed Placemaple Grove, MN 55311-1566 PMA NumberP940019 Supplement NumberS062 Date Received11/14/2022 Decision Date11/28/2022 Product Code NIO  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reas...

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...

WALLSTENT™ ILIAC RP Endoprosthesis

2022-11-22

BOSTON SCIENTIFIC SCIMED, INC.one Scimed Placemaple Grove, MN 55311-1566 PMA NumberP940019 Supplement NumberS061 Date Received10/27/2022 Decision Date11/22/2022 Product Code NIO  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reas...

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...

Blazer II XP Cardiac Ablation Catheter and Cable

2022-11-15

BOSTON SCIENTIFIC150 Baytech Drivesan Jose, CA 95134 PMA NumberP020025 Supplement NumberS137 Date Received10/17/2022 Decision Date11/15/2022 Product Code OAD  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - ...

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PMN

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GUDID

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