BEUDAMED
    FDA Registration Active 🇮🇪 Ireland

    PUNCTUA CRT-D

    Reg #: 9616693 · FEI: 3002618605 · Expires 2025
    View on FDA
    Products
    5
    Proprietary Names
    31
    Establishment Types
    1
    Classifications
    5

    Registration Details

    Registration Name
    Boston Scientific Limited
    Registration Number
    9616693
    FEI Number
    3002618605
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Cashel Road
    City
    CLONMEL Tipperary
    Country
    IE

    Regulatory Submissions

    PMA Number
    P010012

    Owner / Operator

    Firm Name
    Boston Scientific Corporation
    Operator Number
    9912058
    Address
    300 Boston Scientific Way
    City
    Marlborough
    State
    MA
    Postal Code
    01752
    Country
    US

    US Agent

    Business Name
    Boston Scientific Corporation
    Contact Name
    Aaron Dunbar
    Address
    300 Boston Scientific Way
    City
    Marlborough
    State
    MA
    ZIP
    01752
    Country
    US
    Email
    [email protected]
    Phone
    651 3961414

    Products

    Device Name Product Code
    Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) NIK
    Implantable Pulse Generator, Pacemaker (Non-Crt) LWP
    Implantable Cardioverter Defibrillator (Non-Crt) LWS
    Pacemaker/Icd/Crt Non-Implanted Components OSR
    Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode OJX

    Proprietary Names

    PUNCTUA CRT-D INCEPTA CRT-D DYNAGEN CRT-D DYNAGEN X4 CRT-D INOGEN X4 CRT-D CONTAK RENEWAL AVT Software INOGEN CRT-D CONTAK RENEWAL Software Application CONTAK CD Software Application ACUITY X4 Flushing Tool/Wire Guide VIGILIANT CRT-D ACUITY X4 Straight RESONATE HF CRT-D ACUITY X4 Spiral AUTOGEN X4 CRT-D MOMENTUM X4 CRT-D RESONATE CRT-D RESONATE X4 CRT-D VIGILIANT X4 CRT-D MOMENTUM CRT-D EASYTRAK 3 IS-1 CONTAK CD2 Software Application Lead Cap Suture Sleeve ACUITY Spiral EASYTRAK 2 IS-1 AUTOGEN CRT-D ENERGEN CRT-D Bi Directional Torque Wrench EASYTRAK 2 EASYTRAK 3

    Establishment Types

    Manufacture Medical Device