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

    Pulse Generator, Permanent, Implantable

    PMA: P980035 · Supplement: S427 · Decision Jun 27, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    35
    Registration Numbers
    35

    Basic Information

    Device Name
    Pulse Generator, Permanent, Implantable
    Trade Name
    ADVISA SR MRI
    PMA Number
    P980035
    Supplement Number
    S427
    Device Class
    FDA Class 3
    Product Code
    NVZ
    Generic Name
    Pulse generator, permanent, implantable
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    June 27, 2015
    Date Received
    June 3, 2015
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    FOUR (4) MANUFACTURING CHANGES FOR THE ADVISA SR MRI MODEL A3SR01 THAT HAD BEEN PREVIOUSLY APPROVED FOR PREDECESSOR DEVICES TO ALIGN THE ADVISA SR MRIMANUFACTURING PROCESS WITH THE PREDECESSOR DEVICE MANUFACTURING PROCESSES:1) IC SUPPLIER PROCESS FLOW UPDATE TO BICMOS;1) ADDITIONAL LEAK TEST STATION FOR MEDIUM RATE BATTERY; 2) ADDITIONAL WORK STATIONS AT MEDIUM RATE BATTERY SUPPLIER; AND3) FINAL PACK EQUIPMENT IMPLEMENTATION (COQUILPULS LINE) ¿ PHASE II.

    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