Boston Scientific Corp

FDA Filings

This page includes the latest FDA filings for Boston Scientific Corp. 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 Coporation
MAMBA And MAMBA Flex Microcatheters2019-03-15
Boston Scientific Corporation
CoreDx™ Pulmonary Mini-Forceps2019-03-08
Boston Scientific Corporation
Nitinol Thermocouple (TCN) Electrode2019-03-08
Boston Scientific
ISLEEVE Introducer Set2019-03-07
Boston Scientific Corporation
AdVance XP Male Sling2018-11-27
Boston Scientific
ORISE Gel2018-09-28
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
WATCHMAN TruSeal Access System2018-07-20
Boston Scientific Corporation
ISLEEVE Introducer Set2018-06-22
Boston Scientific Inc.
Savion DLVR Guidewire, Savion FLX Guidewire2018-06-18
Boston Scientific Corporation
Ultra ICE Plus – PI 9 MHz Peripheral Imaging Catheter2018-05-17
Boston Scientific
Embozene Color-Advanced Microspheres2018-04-19
Boston Scientific
JUDO 1 Guidewire, JUDO 3 Guidewire, JUDO 6 Guidewire2018-04-12
Boston Scientific Corporation
Imager II Urology Torque Catheter2018-04-10
Boston Scientific
ORISE Tissue Retractor System2018-02-09
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

Latest Premarket Applications

PMAManufacturerDevice NameDate
BOSTON SCIENTIFIC CORPORATION
SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System2019-12-04
Boston Scientific Corp.
AMS 800 Series Product Line/ Artificial Urinary Sphincter with and without InhibiZone Treatment2019-11-27
Boston Scientific Corp.
AMS 700 Series Product Line/ Inflatable Penile Prosthesis (IPP) with and without InhibiZone Treatment2019-11-27
Boston Scientific Corp.
Essentio SR/DR SL, Essentio DR EL, Proponent SR/DR SL, Proponent DR EL, Accolade SR/DR SL, Accolade DR EL, Altrua 2 SR/D2019-11-27
Boston Scientific Corp.
AMS 700 Series Product Line/Inflatable Penile Prosthesis (IPP) with and without InhibiZone Treatment2019-11-27
BOSTON SCIENTIFIC
LATITUDE Programming System2019-11-26
Boston Scientific Corp.
PROMUS PREMIER Everolimus-Eluting Chromium Coronary Stent System (Monorail and Over The Wire) and PROMUS ELITE Everolimu2019-11-26
Boston Scientific Corp.
REBEL Platinum Chromium Coronary Stent System (Monorail and Over-The-Wire)2019-11-26
BOSTON SCIENTIFIC CORPORATION
SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System (Monorail and Over-the-Wire)2019-11-26
Boston Scientific Corp.
Rotablator (Rotablator RotaLink Plus, RotaLink Burr)/ROTAPRO Rotational Atherectomy System (ROTAPRO Plus)2019-11-21
Boston Scientific Corporation
LOTUS Edge Valve System2019-11-21
BOSTON SCIENTIFIC
VENTAK AV AICD VENTAK PRIZM DR/VR, VITALITY, COFIENT, AND TELIGEN AUTOMATIC IMPLANTABLE CARDIOVETER DEFIBRILLATOR SYSTEM2019-11-15
Boston Scientific Corp.
CONTAK CD,EASYTRAK, LIVIAN, COGNIS AND ACUITY SPIRIAL AUTOMATIC IMPLANTABLE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLL2019-11-15
Boston Scientific Corporation
Lotus Edge Valve System2019-11-12
BOSTON SCIENTIFIC
Blazer II XP Cardiac Ablation Catheter and Cable2019-11-07
Boston Scientific Corp.
Blazer II Cardiac Ablation Catheter and Cable2019-11-07
Boston Scientific Corp.
Express SD Monorail Premounted Stent System2019-11-07
Boston Scientific Corp.
PROMUS Element Plus and Promus PREMIER and Promus ELITE Everolimus-Eluting Stent System2019-11-07
Boston Scientific Corp.
REBEL Platinum Chromium Coronary Stent System2019-11-07
Boston Scientific Corp.
Blazer Open Irrigated Temperature Ablation Catheter2019-11-07
Boston Scientific Corp.
Rotablator Rotational Angioplasty System Guidewire with wireClip Torquer2019-11-07
Boston Scientific Corp.
WOLVERINE Coronary Cutting Balloon2019-11-07
Boston Scientific Corp.
Chilli II Cooled Ablation Catheter and Cable2019-11-07
Boston Scientific Corp.
Promus Premier and Promus Elite Everolimus-Eluting Platinum Chromium Coronary Stent System2019-11-01
Boston Scientific Corporation
VICI VENOUS STENT System2019-10-30
BOSTON SCIENTIFIC
Implantable Cardioverter Defibrillator (ICD)2019-10-29
Boston Scientific Corp.
Non-MRI Pacemakers2019-10-29
Boston Scientific Corp.
Cardiac Resynchronization Therapy Defibrillator (CRT-D)2019-10-29
BOSTON SCIENTIFIC CORPORATION
Subcutaneous Implantable Cardioverter Defibrillator (S-ICD)2019-10-29
Boston Scientific Corp.
Precision Spectra, Spectra WaveWriter, Precision Novi, Precision Montage and Precision Montage MRI Spinal Cord Stimulato2019-10-20

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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