BEUDAMED
    FDA PMA FDA Class 3 30-Day Notice Accepted 🇺🇸 United States

    Implantable Cardioverter Defibrillator (Non-Crt)

    PMA: P950022 · Supplement: S012 · Decision Jan 18, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49

    Basic Information

    Device Name
    Implantable Cardioverter Defibrillator (Non-Crt)
    Trade Name
    CADENCE FAMILY OF IMPLANTABLE CARDIOVERTER DEFIBRILLATORS AND THE TVL LEAD SYSTEM
    PMA Number
    P950022
    Supplement Number
    S012
    Device Class
    FDA Class 3
    Product Code
    LWS
    Generic Name
    Implantable cardioverter defibrillator (non-CRT)
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    January 18, 2001
    Date Received
    December 19, 2000
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    USE OF AN ALTERNATE STERILIZATION CHAMBER FOR THE ICDS AND TACHYCARDIA LEADS AND IS ALSO REQUESTING APPROVAL FOR USE OF PARAMETRIC RELEASE AS AN ALTERNATE TO THE CURRENT USE OF BIOLOGICAL INDICATORS IN THE RELEASE OF STERILIZED PRODUCTS.

    Classifications

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

    Product Code Device Name
    LWS Implantable Cardioverter Defibrillator (Non-Crt)