BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Pulse Generator, Permanent, Implantable

    PMA: P910023 · Supplement: S081 · Decision May 11, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    35
    Registration Numbers
    35

    Basic Information

    Device Name
    Pulse Generator, Permanent, Implantable
    Trade Name
    CONVERT (MODEL V-191) AND CONVERT+ (MODEL V-195) SYSTEMS WITH APPLICATION SOFTWARE MODEL 3307 VERSION 4.9
    PMA Number
    P910023
    Supplement Number
    S081
    Device Class
    FDA Class 3
    Product Code
    NVZ
    Generic Name
    Pulse generator, permanent, implantable
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    May 11, 2006
    Date Received
    August 8, 2005
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE CONVERT AND CONVERT+ ICD SYSTEMS WITH THE APPLICATION SOFTWARE MODEL 3307 VERSION 4.9. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME CONVERT AND CONVERT+ ICD SYSTEMS AND IS INDICATED TO PROVIDE VENTRICULAR ANTITACHYCARDIA PACING (MODEL V-195 ONLY) AND VENTRICULAR DEFIBRILLATION FOR AUTOMATED TREATMENT OF LIFE-THREATENING VENTRICULAR ARRHYTHMIAS.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    NVZ Pulse Generator, Permanent, Implantable