Boston Scientific

FDA Filings

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

FDA Registration(s)
FDA Owner/Operator Registration

































FDA Filings

Device
Company
DeviceDate
BOSTON SCIENTIFIC
RELIANCE 4-FRONT Steroid-eluting Pace/Sense and Defibrillation Lead2021-06-08
BOSTON SCIENTIFIC
SWEET TIP(R) RX STEROID ELUTING LEAD2021-05-10
BOSTON SCIENTIFIC
THINLINE ENDOCARDIAL PACING LEADS2021-05-10
BOSTON SCIENTIFIC
VENTAK(R) P2 SYSTEM2021-05-10
BOSTON SCIENTIFIC
VENTAK(R) PRX (TM) MODEL 1700,1705 PULSE GENERATOR2021-05-10
BOSTON SCIENTIFIC
ENDOTAK LEAD SYSTEM2021-05-10
BOSTON SCIENTIFIC
VENTAK AND AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (AICD) SYSTEMS2021-05-10
BOSTON SCIENTIFIC
ORIGEN MINI ICD VR, ORIGEN MINI ICD DR, INOGEN MINI ICD VR, INOGEN MINI ICD DR, DYNAGEN MINI ICD VR, DYNAGEN MINI ICD DR2021-05-06
BOSTON SCIENTIFIC
ORIGEN MINI ICD VR, ORIGEN MINI ICD DR, INOGEN MINI ICD VR, INOGEN MINI ICD DR, DYNAGEN MINI ICD VR, DYNAGEN MINI ICD DR2021-04-30
Boston Scientific
Flexiva Pulse Laser Fiber, Flexiva Pulse Tractip Laser Fiber, Flexiva Pulse ID Laser Fiber, Flexiva Pulse ID TracTip Laser Fiber2021-04-28
BOSTON SCIENTIFIC
Implantable Pulse Generator Test Magnet2021-04-16
BOSTON SCIENTIFIC
IntellaTip MiFi Filter Module and IntellaTip MiFi Reference Cable2021-04-08
BOSTON SCIENTIFIC
VENTAK AV & VENTAK PRIZM DR/VR, VITALITY, CONFIENT, TELIGEN, PUNCTUA ICD, ENERGEN ICD, INCEPTA ICD, ORIGEN ICD, INOGEN I2021-04-02
BOSTON SCIENTIFIC
SWEET TIP Rx, SWEET PICOTIO Rx, and FLEXTEND2021-04-02
BOSTON SCIENTIFIC
THINLINE/FINELINE Family of Endocardial Pacing Leads2021-04-02
BOSTON SCIENTIFIC
SELUTE Lead System2021-04-02
BOSTON SCIENTIFIC
VIGOR DR/SR, DISCOVERY, and MERIDIAN2021-04-02
BOSTON SCIENTIFIC
VENTAK P2 System2021-04-02
BOSTON SCIENTIFIC
VENTAK PRx and VENTAK MINI2021-04-02
BOSTON SCIENTIFIC
ENDOTAK Lead System2021-04-02
BOSTON SCIENTIFIC
VENTAK P2021-04-02
BOSTON SCIENTIFIC
DELTA/VISTA2021-04-02
BOSTON SCIENTIFIC
VENTAK2021-04-02
BOSTON SCIENTIFIC
COSMOS System2021-04-02
BOSTON SCIENTIFIC
LATITUDE Programming System2021-02-02
BOSTON SCIENTIFIC
FLEXTEND® Bipolar, Steroid Eluting, Extendable/Retractable Pacing Lead2021-01-13
BOSTON SCIENTIFIC
FINELINE™ II Sterox, Endocardial Pacing Lead, Passive Fixation2021-01-13
BOSTON SCIENTIFIC
Endotak Lead System2021-01-13
Boston Scientific
ILab Polaris Multi-Modality Guidance System2020-05-29
Boston Scientific
ISLEEVE Introducer Set2019-03-07
Boston Scientific
ORISE Gel2018-09-28
Boston Scientific
WATCHMAN TruSeal Access System2018-07-20
Boston Scientific
Embozene Color-Advanced Microspheres2018-04-19
Boston Scientific
JUDO 1 Guidewire, JUDO 3 Guidewire, JUDO 6 Guidewire2018-04-12
Boston Scientific
ORISE Tissue Retractor System2018-02-09
Boston Scientific
Expect Slimline (SL) Endoscopic Ultrasound Aspiration Needle2017-10-27
BOSTON SCIENTIFIC
Expect Slimline (SL) Endoscopic Ultrasound Aspiration Needle2017-01-30
BOSTON SCIENTIFIC
Symphion Endoscope And Symphion Cervical Sheath2016-06-14
BOSTON SCIENTIFIC
WallFlex Biliary RX Fully Covered Stent System RMV2016-06-03

Similar & Related FDA Registered Companies

Related Finance Registrations
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
2020091254765Ringaskiddy,Ireland -> Wilmington, North CarolinaMEDICAL DEVICES ORCA POD 3 BOX STC 216 PIECES PACKED ON 6 PALLETS INVOICE # 973686128 PO# 6000227292 HS-CODE 901839006 PCS
2020070216342Shanghai ,China (Mainland) -> Boston, MassachusettsCOMMUNICATOR LATITUDE WAVE MIC10 PKG
2020063030394Liverpool,United Kingdom -> New York/Newark Area, Newark, New JerseyMEDICAL DEVICES SG TRANSRADIAL LC HYPOTUBE STC 18 CARTONS PACKED ON 1 PALLET INVOICE # 36003574 & 36003575 HS-CODE 9018390018 PKG
2020062640601Liverpool,United Kingdom -> New York/Newark Area, Newark, New JerseyMEDICAL DEVICES SG TRANSRADIAL LC HYPOTUBE STC 18 CARTONS PACKED ON 1 PALLET INVOICE # 36003574 & 36003575 HS-CODE 9018390018 PKG
2020061958800Liverpool,United Kingdom -> New York/Newark Area, Newark, New JerseyMEDICAL DEVICES SG TRANSRADIAL LC HYPOTUBE STC 18 CARTONS PACKED ON 1 PALLET INVOICE # 36003574 & 36003575 HS-CODE 9018390018 PKG
2020060455537Liverpool,United Kingdom -> New York/Newark Area, Newark, New JerseyMEDICAL DEVICES SG TRANSRADIAL LC HYPOTUBE PACKED ON 1 PALLET INVOICE # 1002167 HS-CODE 9018390012 PKG
2020052127964Shanghai ,China (Mainland) -> Seattle, WashingtonCOMMUNICATOR LATITUDE WAVE MIC20 CTN
2020051841215Shanghai ,China (Mainland) -> Seattle, WashingtonCOMMUNICATOR LATITUDE WAVE MIC20 CTN

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