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

    Pulse Generator, Permanent, Implantable

    PMA: P980035 · Supplement: S294 · Decision Feb 8, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    35
    Registration Numbers
    35

    Basic Information

    Device Name
    Pulse Generator, Permanent, Implantable
    Trade Name
    ADVISA DR MRI A2DR01 IMPLANTABLE PULSE GENERATOR SOFTWARE MODEL 9995
    PMA Number
    P980035
    Supplement Number
    S294
    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
    February 8, 2013
    Date Received
    September 26, 2012
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    ADDITIONAL IN-PROCESS INSPECTION OF THE HYBRID CATHODE MIX RATIO, NEW PRESSURE TEST EQUIPMENT, NEW MANUFACTURING LINES IN AN EXTENDED CONTROLLED ENVIRONMENT AREA,CMOS PROCESS FLOW CHANGES, AN UPDATE TO TEST SOFTWARE AND HARDWARE FOR INTEGRATED CIRCUITS, THE IMPLEMENTATION OF FACTORYWORKS RELEASE 8.0 AND MES WEB SERVICES RELEASE 2.1, ANDUPDATES TO THE IC WAFER PROBE TEST SPECIFICATIONS AND TEST SOFTWARE.

    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