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

    Implantable Cardioverter Defibrillator (Non-Crt)

    PMA: P980016 · Supplement: S306 · Decision Jul 15, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49

    Basic Information

    Device Name
    Implantable Cardioverter Defibrillator (Non-Crt)
    Trade Name
    MAXIMO II/SECURA/VIRTUOSO II
    PMA Number
    P980016
    Supplement Number
    S306
    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
    July 15, 2011
    Date Received
    June 10, 2011
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    SIX CHANGES TO GEN2 HYBRID TESTER: 1) A CHANGE TO THE TEST DECIBEL LIMIT OF THE EGM CMR; 2) A CHANGE TO THE TELEMETRY B VIZSENSE; 3) A CHANGE TO THE R034 STRESS; 4) A CHANGE TO THE JTAG FULL ENERGY DELIVERY PULSE WIDTH; 5) A CHANGE TO LV1 CONTINUITY; AND 6) A CHANGE TO THE CURRENT DRAIN AVVD RF IDD.

    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)