BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Pulse Generator, Permanent, Implantable

    PMA: P980035 · Supplement: S045 · Decision Sep 30, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    35
    Registration Numbers
    35

    Basic Information

    Device Name
    Pulse Generator, Permanent, Implantable
    Trade Name
    ENRHYTHM IPG
    PMA Number
    P980035
    Supplement Number
    S045
    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
    September 30, 2005
    Date Received
    July 26, 2005
    Supplement Type
    135 Review Track For 30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL TO VERIFY ADDITIONAL PROGRAMMING PARAMETERS AT THE POST-STERILIZATION MANUFACTURING STEP. THE DEVICES, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES ENTRUST IMPLANTABLE CARDIOVERTER DEFIBRILLATOR AND ENRHYTHM IMPLANTABLE PULSE GENERATOR RESPECTIVELY.

    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