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

    Pulse Generator, Permanent, Implantable

    PMA: P980035 · Supplement: S418 · Decision Apr 21, 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
    S418
    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
    April 21, 2015
    Date Received
    March 24, 2015
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    FOURTEEN (14) MANUFACTURING CHANGES FOR ADVISA SR MRI THAT HAD BEEN PREVIOUSLY REVIEWED AND ACCEPTED TO ALIGN THE ADVISA SR MRI MANUFACTURING PROCESS WITH THE PREDECESSOR DEVICE MANUFACTURING PROCESSES:1) TOOLING CHANGES AND ALTERNATE SUPPLIER FOR FT INSULATOR; 2) MANUFACTURING PROCESS CHANGE FOR PRINTED WIRING BOARD SUBSTRATES; 3) LEAK CHECK TESTER WITH SOFTWARE UPDATES; 4) NEW MATERIAL SUPPLIER AND SPECIFICATION UPDATE FOR P(ETFE); 5) PLASMA CLEANING PROCESS CHANGE; 6) FACTORYWORKS RELEASE 7.11; AND7) SPACE DATA COLLECTOR TRACKING SYSTEM UPDATE AT NIKON ROUT; 8) UPDATE TO FINAL ASSEMBLY PROCESSING TEMPERATURE REQUIREMENTS 9) UNIVERSAL BURN IN TEST SYSTEM (UBITS) SOFTWARE UPDATE; 10) MODIFY IN-PROCESS BATTERY INSPECTION REQUIREMENTS; 11) VISION SYSTEM IMPLEMENTATION AT MJC STERILIZATION AREA; 12) VISION SYSTEM FOR CONNECTOR AND RADIOPAQUE VERIFICATION AT SMO; 13) IC DIE SORTER EQUIPMENT SOFTWARE CONFIGURATION UPDATE; AND 14) FINAL VISUAL CRITERIA CHANGE.

    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