BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implantable Pulse Generator, Pacemaker (Non-Crt)

    PMA: P820076 · Supplement: S020 · Decision Dec 22, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    35
    Registration Numbers
    35

    Basic Information

    Device Name
    Implantable Pulse Generator, Pacemaker (Non-Crt)
    Trade Name
    BIOTRONIK GEMNOS 04, 04A, AND TC 04
    PMA Number
    P820076
    Supplement Number
    S020
    Device Class
    FDA Class 3
    Product Code
    LWP
    Generic Name
    Implantable pulse generator, pacemaker (non-CRT)
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    December 22, 1995
    Date Received
    May 4, 1995
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE CHANGE IN THE BURN-IN PROCESSING OF THE WILSON GREATBATCH BATTERIES WHICH ARE USED IN YOUR LISTED PACEMAKERS. THIS PROCESS CHANGE IS A REDUCTION OF THE BATTERY BURN-IN TIME FROM 35 DAYS TO 4 DAYS

    Classifications

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

    Product Code Device Name
    LWP Implantable Pulse Generator, Pacemaker (Non-Crt)