BOSTON SCIENTIFIC CORPORATION

FDA Filings

This page includes the latest FDA filings for BOSTON SCIENTIFIC CORPORATION. Currently, you will find the latest 25 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

Latest Premarket Notifications

ManufacturerDevice NameDate
Boston Scientific Corporation
AXIOS Stent And Electrocautery Enhanced Delivery System2019-08-26
Boston Scientific Corporation
Tria Soft Ureteral Stent2019-08-16
Boston Scientific Corporation
15F ISLEEVE Introducer Set, 14F ISLEEVE Introducer Set2019-08-07
Boston Scientific Corporation
Stonetome Stone Removal Device2019-07-25
Boston Scientific Corporation
ILab Polaris Multi-Modality Guidance System2019-07-02
Boston Scientific Corporation
Tria Firm Ureteral Stent2019-05-24
Boston Scientific Corporation
MAKO 72019-05-21
Boston Scientific Corporation
Tactra Penile Prosthesis, 9.5 Mm Device, Tactra Penile Prosthesis, 11 Mm Device, Tactra Penile Prosthesis, 13 Mm Device2019-04-16
Boston Scientific Corporation
AXIOS Stent And Delivery System, AXIOS Stent And Electrocautery Enhanced Delivery System2019-03-25
Boston Scientific Corporation
CoreDx™ Pulmonary Mini-Forceps2019-03-08
Boston Scientific Corporation
Nitinol Thermocouple (TCN) Electrode2019-03-08
Boston Scientific Corporation
AdVance XP Male Sling2018-11-27
Boston Scientific Corporation
Magic Torque DLVR Guidewire2018-09-26
Boston Scientific Corporation
Agile Esophageal Stent System2018-09-21
Boston Scientific Corporation
Seal Single Use Biopsy Valve2018-09-13
Boston Scientific Corporation
SpyGlass DS And DS II Direct Visualization System2018-08-23
Boston Scientific Corporation
RHYTHMIA HDx Mapping System (with Software Version 2.0)2018-07-25
Boston Scientific Corporation
ISLEEVE Introducer Set2018-06-22
Boston Scientific Corporation
Ultra ICE Plus – PI 9 MHz Peripheral Imaging Catheter2018-05-17
Boston Scientific Corporation
Imager II Urology Torque Catheter2018-04-10
Boston Scientific Corporation
OptiCross 6 HD, 60 MHz Coronary Imaging Catheter (Paper DFU), OptiCross 6 HD, 60 MHz Coronary Imaging Catheter (e-DFU)2018-01-17
Boston Scientific Corporation
Amplatz Type Renal Sheaths, Amplatz Type Renal Sheath Set, And Clear Renal Sheath2018-01-10
Boston Scientific Corporation
Advantage/Advantage Fit Delivery Device, Lynx Delivery Device, Obtryx Delivery Device (Curved & Halo), Obtryx II Delivery Device (Curved & Halo), Solyx SIS Delivery Device2017-12-20
Boston Scientific Corporation
LumiCoil Platinum Fiducial Marker2017-12-19
Boston Scientific Corporation
Polyform Synthetic Mesh2017-12-15
Boston Scientific Corporation
OptiCross HD, 60 MHz Coronary Imaging Catheter (Paper DFU); OptiCross HD, 60 MHz Coronary Imaging Catheter (e-DFU)2017-11-16
Boston Scientific Corporation
WATCHDOG Hemostasis Valve Kit2017-11-09
Boston Scientific Corporation
Emerge PTCA Dilatation Catheter2016-12-14
BOSTON SCIENTIFIC CORPORATION
Maverick XL Percutaneous Transluminal Coronary Angioplasty Monorail Dilatation Cathete2016-12-14
Boston Scientific Corporation
Coyote Monorail Percutaneous Transluminal Angioplasty Balloon Dilatation Catheter, Express SD Biliary Monorail Premounted Stent System, Maverick XL Percutaneous Transluminal Coronary Angioplasty Monorail Dilatation Catheter, Sterling Monorail Percuta2016-11-04

Latest Premarket Applications

PMAManufacturerDevice NameDate
Boston Scientific Corporation
LOTUS Edge Valve System2019-11-21
Boston Scientific Corporation
Lotus Edge Valve System2019-11-12
Boston Scientific Corporation
VICI VENOUS STENT System2019-10-30
BOSTON SCIENTIFIC CORPORATION
Subcutaneous Implantable Cardioverter Defibrillator (S-ICD)2019-10-29
Boston Scientific Corporation
LOTUS Edge Valve System2019-10-13
BOSTON SCIENTIFIC CORPORATION
EMBLEM S-ICD Electrode2019-10-10
BOSTON SCIENTIFIC CORPORATION
Innova Vascular Self Expanding Stent System2019-10-07
BOSTON SCIENTIFIC CORPORATION
Wallstent Venous RP & Endoprosthesis with Unistep Plus2019-10-07
Boston Scientific Corporation
LOTUS Edge Valve System2019-10-03
Boston Scientific Corporation
LOTUS Edge Valve System2019-09-26
BOSTON SCIENTIFIC CORPORATION
Innova Vascular Self-Expanding Stent System2019-09-23
BOSTON SCIENTIFIC CORPORATION
Synergy Everolimus-Eluting Platinum Chromium Coronary Stent System2019-09-13
BOSTON SCIENTIFIC CORPORATION
Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) pulse generator (PG) high voltage (HV) capacitor stack2019-09-13
BOSTON SCIENTIFIC CORPORATION
Innova Vascular Self-Expanding Stent System2019-09-06
Boston Scientific Corporation
LOTUS Edge Valve System2019-08-21
BOSTON SCIENTIFIC CORPORATION
Synergy Everolimus-Eluting Platinum Chromium Coronary Stent System2019-08-20
Boston Scientific Corporation
LOTUS Edge Valve System2019-08-15
BOSTON SCIENTIFIC CORPORATION
SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System (Monorail)2019-08-09
Boston Scientific Corporation
LOTUS Edge Valve System2019-07-25
BOSTON SCIENTIFIC CORPORATION
WALLSTENT ENDOPROSTHESIS2019-07-25
BOSTON SCIENTIFIC CORPORATION
SYNERGY EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM2019-07-25
BOSTON SCIENTIFIC CORPORATION
INNOVA VASCULAR SELF-EXPANDING STENT WITH DELIVERY SYSTEM2019-07-25
BOSTON SCIENTIFIC CORPORATION
EXPRESS LD ILIAC PREMOUNTED STENT SYSTEM2019-07-25
BOSTON SCIENTIFIC CORPORATION
EMBLEM Subcutaneous Implantable Cardioverter Defibrillator (S-ICD)2019-07-11
Boston Scientific Corporation
LOTUS Edge Valve System2019-06-22
Boston Scientific Corporation
LOTUS Edge Valve System2019-06-19
BOSTON SCIENTIFIC CORPORATION
Express LD Premounted Iliac Stent System (ELD)2019-06-18
BOSTON SCIENTIFIC CORPORATION
Innova Vasculaar Self-Expanding Stent System2019-06-18
BOSTON SCIENTIFIC CORPORATION
SYNERGY EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM2019-06-14
BOSTON SCIENTIFIC CORPORATION
SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System2019-06-11

Latest De Novo Filings

De NovoManufacturerDevice NameDate

GUDID Registrations

Device GUDID
Device Name
ManufacturerDate
Hydra®
BOSTON SCIENTIFIC CORPORATION2019-11-27
Hydra®
BOSTON SCIENTIFIC CORPORATION2019-11-27
Hydra®
BOSTON SCIENTIFIC CORPORATION2019-11-27
Hydra®
BOSTON SCIENTIFIC CORPORATION2019-11-27
Hydra®
BOSTON SCIENTIFIC CORPORATION2019-11-27
Hydra®
BOSTON SCIENTIFIC CORPORATION2019-11-27
Hydra®
BOSTON SCIENTIFIC CORPORATION2019-11-27
Hydra®
BOSTON SCIENTIFIC CORPORATION2019-11-27
Hydra®
BOSTON SCIENTIFIC CORPORATION2019-11-27
Hydra®
BOSTON SCIENTIFIC CORPORATION2019-11-27
Hydra®
BOSTON SCIENTIFIC CORPORATION2019-11-27
Hydra®
BOSTON SCIENTIFIC CORPORATION2019-11-27
rezum
BOSTON SCIENTIFIC CORPORATION2019-11-19
Genesys HTA System
BOSTON SCIENTIFIC CORPORATION2019-11-18
Genesys HTA System
BOSTON SCIENTIFIC CORPORATION2019-11-18
Navigator
BOSTON SCIENTIFIC CORPORATION2019-11-18
Navigator
BOSTON SCIENTIFIC CORPORATION2019-11-18
Navigator
BOSTON SCIENTIFIC CORPORATION2019-11-18
Navigator
BOSTON SCIENTIFIC CORPORATION2019-11-18
Navigator
BOSTON SCIENTIFIC CORPORATION2019-11-18
Navigator
BOSTON SCIENTIFIC CORPORATION2019-11-18
Navigator
BOSTON SCIENTIFIC CORPORATION2019-11-18
Navigator
BOSTON SCIENTIFIC CORPORATION2019-11-18
Navigator
BOSTON SCIENTIFIC CORPORATION2019-11-18
Navigator
BOSTON SCIENTIFIC CORPORATION2019-11-18
Navigator
BOSTON SCIENTIFIC CORPORATION2019-11-18
Navigator
BOSTON SCIENTIFIC CORPORATION2019-11-18
ZOOM® LATITUDE®
BOSTON SCIENTIFIC CORPORATION2019-11-15
EMBLEM™ S-ICD Programmer
BOSTON SCIENTIFIC CORPORATION2019-11-14
LATITUDE™ Programming System
BOSTON SCIENTIFIC CORPORATION2019-11-12
EMBLEM™ S-ICD
BOSTON SCIENTIFIC CORPORATION2019-11-08
Symphion
BOSTON SCIENTIFIC CORPORATION2019-11-08
Symphion
BOSTON SCIENTIFIC CORPORATION2019-11-08
VISIONIST™ X4 CRT-P
BOSTON SCIENTIFIC CORPORATION2019-11-08
VISIONIST™ CRT-P
BOSTON SCIENTIFIC CORPORATION2019-11-08

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