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
IntellaNav XP and IntellaNav MiFi XP ablation catheters2020-06-17
BOSTON SCIENTIFIC
LATITUDE Wave Communicators2020-06-12
BOSTON SCIENTIFIC
Blazer Prime HTD cardiac ablation catheter2020-06-04
Boston Scientific
ILab Polaris Multi-Modality Guidance System2020-05-29
BOSTON SCIENTIFIC
Blazer II XP Cardiac Ablation Catheter and Cable2020-05-19
BOSTON SCIENTIFIC
ICD ORIGEN VR, ICD ORIGEN DR, ICD INOGEN VR, ICD INOGEN DR, ICD DYNAGEN VR, ICD DYNAGEN DR, ICD AUTOGEN VR, ICD AUTOGEN2020-04-07
BOSTON SCIENTIFIC
LATITUDE NXT System - LATITUDE NXT Patient Management System, LATITUDE Wave Communicator and LATITUDE NXT System Server2020-04-01
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 DR2020-03-17
BOSTON SCIENTIFIC
ICD ORIGEN VR, ICD ORIGEN DR, ICD INOGEN VR, ICD INOGEN DR, ICD DYNAGEN VR, ICD DYNAGEN DR, ICD AUTOGEN VR, ICD AUTOGEN2020-03-05
BOSTON SCIENTIFIC
IntellaTip MiFi XP, IntellaNav MiFi XP and IntellaNav XP Temperature Ablation Catheters2020-02-19
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
BOSTON SCIENTIFIC
Express SD Biliary Monorail Premounted Stent System2015-10-27
BOSTON SCIENTIFIC
Permanent Sled Bag2015-09-22
BOSTON SCIENTIFIC
ILab Ultrasound Imaging System2015-09-18

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