FDA.reportPublic FDA data

BOSTON SCIENTIFIC CORPORATION

Matched from indexed company URL: Boston Scientific Corporation

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
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
689131511121162P980037ANGIOJET RHEOLYTIC THROMBECTOMY LF140 CATHETERMCX1999-03-12
267561511121162P980037ANGIOJET RHEOLYTIC THROMBECTOMY LF140 CATHETERMCX1999-03-12
771901511121162P980037ANGIOJET RHEOLYTIC THROMBECTOMY LF140 CATHETERMCX1999-03-12
1221951511121162P980037ANGIOJET RHEOLYTIC THROMBECTOMY LF140 CATHETERMCX1999-03-12
1756291511121162P980037ANGIOJET RHEOLYTIC THROMBECTOMY LF140 CATHETERMCX1999-03-12
1222011511121162P980037ANGIOJET RHEOLYTIC THROMBECTOMY LF140 CATHETERMCX1999-03-12
1756291517525685P980033WALLSTENT ENDOPROSTHESISQKJ2001-11-16
1221951517525685P980033WALLSTENT 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
1756291352338383P950020FLEXATOME CUTTING BALLOONNWX2000-04-18
1221951352338383P950020FLEXATOME CUTTING BALLOONNWX2000-04-18
1756291747021444P940019WALLSTENT(R) ILIAC ENDOPROSTHESISNIO1996-05-28
1221951747021444P940019WALLSTENT(R) ILIAC ENDOPROSTHESISNIO1996-05-28
1221951465109137P930035VENTAK(R) P2 SYSTEMLWS1995-03-10
1756291419367627P930031WALLSTENT(R) TIPS ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEMMIR1995-09-29
1221951419367627P930031WALLSTENT(R) TIPS ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEMMIR1995-09-29
1221951923360514P920047EPT-1000 CARDIAC ABLATION SYSTEMLPB1994-10-28
1756291923360514P920047EPT-1000 CARDIAC ABLATION SYSTEMLPB1994-10-28
1036181923360514P920047EPT-1000 CARDIAC ABLATION SYSTEMLPB1994-10-28
1221952072263923P910077VENTAK(R) PRX (TM) MODEL 1700,1705 PULSE GENERATORLWS1994-06-17
1222011708953900P910073ENDOTAK LEAD SYSTEMLWS1993-08-26
1221951708953900P910073ENDOTAK LEAD SYSTEMLWS1993-08-26
1756291708953900P910073ENDOTAK LEAD SYSTEMLWS1993-08-26
689131042955031P900056ROTABLATOR(R)MCX1993-05-28
267561042955031P900056ROTABLATOR(R)MCX1993-05-28
771901042955031P900056ROTABLATOR(R)MCX1993-05-28
1221951042955031P900056ROTABLATOR(R)MCX1993-05-28
1756291042955031P900056ROTABLATOR(R)MCX1993-05-28
1036181042955031P900056ROTABLATOR(R)MCX1993-05-28
1221951338635668P890055MEDSTREAM PROGRAMMABLE INFUSION PUMP SYSTEMLKK1996-03-11
689131361749618P860019SCIMED PTCA DILATATION CATHETERLOX1986-11-28
1221951361749618P860019SCIMED PTCA DILATATION CATHETERLOX1986-11-28
1221951933696276P830060VENTAK AND AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (AICD) SYSTEMSLWS1985-10-04
1221951291648365P230035AGENT Paclitaxel-Coated Balloon CatheterOOB2024-02-29
689131291648365P230035AGENT 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
1221951414172803P200029TheraSphereNAW2021-03-17
689131414172803P200029TheraSphereNAW2021-03-17
689131580189764P190019Ranger™ Paclitaxel-Coated PTA Balloon CatheterONU2020-10-30
1756291580189764P190019Ranger™ Paclitaxel-Coated PTA Balloon CatheterONU2020-10-30
1221951580189764P190019Ranger™ Paclitaxel-Coated PTA Balloon CatheterONU2020-10-30
1221951888768123P190006Axonics Sacral Neuromodulation SystemQON2019-09-06
1221951332365242P180046Axonics Sacral Neuromodulation SystemEZW2019-11-13
689161219392652P180029LOTUS Edge Valve SystemNPT2019-04-23
1756291040963809P180011Eluvia Drug-Eluting Vascular Stent SystemNIU2018-09-18
1221951040963809P180011Eluvia Drug-Eluting Vascular Stent SystemNIU2018-09-18
689131040963809P180011Eluvia Drug-Eluting Vascular Stent SystemNIU2018-09-18
1221951712452773P170023Bulkamid Urethral Bulking SystemLNM2020-01-28
1222011401702589P150031VERCISE DEEP BRAIN STIMULATION (DBS)SYSTEMNHL2017-12-08
1221951401702589P150031VERCISE 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
1221951846987198P150005BLAZER OPEN-IRRIGATED ABLATION CATHETEROAD2016-02-24
771901846987198P150005BLAZER OPEN-IRRIGATED ABLATION CATHETEROAD2016-02-24
1783981846987198P150005BLAZER OPEN-IRRIGATED ABLATION CATHETEROAD2016-02-24
1756291846987198P150005BLAZER OPEN-IRRIGATED ABLATION CATHETEROAD2016-02-24
689131719286576P150003SYNERGY EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEMNIQ2015-10-02
1756291719286576P150003SYNERGY EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEMNIQ2015-10-02
1221951719286576P150003SYNERGY EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEMNIQ2015-10-02
689131833215550P140028INNOVA VASCULAR SELF-EXPANDING STENT WITH DELIVERY SYSTEMNIP2015-07-21
1756291833215550P140028INNOVA VASCULAR SELF-EXPANDING STENT WITH DELIVERY SYSTEMNIP2015-07-21
1221951833215550P140028INNOVA 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
689131649464100P130030REBEL 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
1221951649464100P130030REBEL PLATINUM CHROMIUM CORONARY STENT SYSTEM MONORAIL AND OVER THE WIREMAF2026-03-10
689131951386063P130013WATCHMAN LEFT ATRIAL APPENDAGE (LAA) CLOSURE TECHNOLOGYNGV2015-03-13
1756291951386063P130013WATCHMAN LEFT ATRIAL APPENDAGE (LAA) CLOSURE TECHNOLOGYNGV2015-03-13
1221951951386063P130013WATCHMAN 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
1756291310175420P110035EPIC SELF-EXPANDING NITINOL STENT SYSTEMNIO2012-04-13
1221951310175420P110035EPIC SELF-EXPANDING NITINOL STENT SYSTEMNIO2012-04-13
1756291144344264P110010PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEMNIQ2011-11-22
1221951144344264P110010PROMUS 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
689131384799466P060006BOSTON SCIENTIFIC EXPRESS SD RENAL MONORAIL PREMOUNTED STENT SYSTEMNIN2008-12-11
1756291384799466P060006BOSTON SCIENTIFIC EXPRESS SD RENAL MONORAIL PREMOUNTED STENT SYSTEMNIN2008-12-11
1221951384799466P060006BOSTON SCIENTIFIC EXPRESS SD RENAL MONORAIL PREMOUNTED STENT SYSTEMNIN2008-12-11
1222011326445800P050046ACUITY STEERABLE LEAD SYSTEMOJX2007-04-13
1221951326445800P050046ACUITY 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
1221951842603510P020025EP TECHNOLOGIES EPT-1000 XP RF ABLATION SYSTEMOAD2003-08-25
1783981842603510P020025EP TECHNOLOGIES EPT-1000 XP RF ABLATION SYSTEMOAD2003-08-25
771901842603510P020025EP TECHNOLOGIES EPT-1000 XP RF ABLATION SYSTEMOAD2003-08-25
1756291842603510P020025EP TECHNOLOGIES EPT-1000 XP RF ABLATION SYSTEMOAD2003-08-25
1036181842603510P020025EP 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
1222011452976857P010012CONTAK CD,EASYTRAK, LIVIAN, COGNIS AND ACUITY SPIRIAL AUTOMATIC IMPLANTABLE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLLNIK2002-05-02
1221951294619430P000053AMS SPHINCTER 800 URINARY CONTROL SYSTEMEZY2001-06-14
267391294619430P000053AMS SPHINCTER 800 URINARY CONTROL SYSTEMEZY2001-06-14
267391738469868P000040HYDRO THERMABLATOR ENDOMETRIAL ABLATION SYSTEMMNB2001-04-20
267441738469868P000040HYDRO THERMABLATOR ENDOMETRIAL ABLATION SYSTEMMNB2001-04-20
771901738469868P000040HYDRO THERMABLATOR ENDOMETRIAL ABLATION SYSTEMMNB2001-04-20
1221951209277977P000020STINGER ABLATION CATHETER; TEMPLINK EXTENSION CABLELPB2000-11-29
267391442909449N970012AMS 700 SERIES PRODUCT LINE AND THE DYNAFLEX INFLATABLE PENILE PROSTHESESJCW1998-11-02
1221951442909449N970012AMS 700 SERIES PRODUCT LINE AND THE DYNAFLEX INFLATABLE PENILE PROSTHESESJCW1998-11-02
1221951012192267N970003PULSAR/PULSAR MAX IMPLANTABLE PULSE GENERATOR SYSTEM WITH CONSULT SOFTWARELWP1999-06-03
267441319344908K994252INTRODUCER SHEATHS, VESSEL DILATOR, GUIDEWIREDYB2000-01-04
1221951584371273K992863LEAD STYLET,MODELS 6505,6506,6507,6508DRB1999-11-12
1221951348099187K992373ORBITER ST DIAGNOSTIC ELECTRODE CATHETER & ORBITER ST EXTENSION CABLEDRF1999-11-05
1756291348099187K992373ORBITER ST DIAGNOSTIC ELECTRODE CATHETER & ORBITER ST EXTENSION CABLEDRF1999-11-05

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DQX792022-12-19
FGE722025-07-03
DQY552024-02-01
GEX472026-05-18
DQK372026-08-21
KNS362025-06-11
LIT362024-07-10
DRF352025-06-27
GEH342024-10-18
LOX332022-03-24
FAD322025-04-15
DYB282025-03-20
QEY252022-04-20
ODG242026-06-17
OBJ242026-04-08
KRD232024-10-03
FDI222020-10-08
FGB212026-08-26
QEZ202012-06-06
QEW192024-05-29
GEI182016-07-07
KRA172026-05-15
MCW172022-09-06
DQO172015-10-29
FED162026-08-04
PKL162025-02-06
OTN162023-06-29
ODC152025-10-09
EOQ142023-03-02
KNT122021-04-27
ITX122020-04-17
MCX121999-03-12
KOD112018-04-10
DRE102024-07-12
OCW102023-06-29
GXI102019-03-08
OAD102016-02-24
LWS102012-09-28
DXF92024-11-01
LQR92021-05-26

NDC#

PMA#

200 records. Showing 1-40. Next

PMN#

200 records. Showing 1-40. Next

GUDID#

200 records. Showing 1-40. Next