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

    Pulse Generator, Permanent, Implantable

    PMA: P980035 · Supplement: S419 · 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
    S419
    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

    NINE (9) 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) ANTENNA WIRE BOND COAT MANUFACTURING STANDARDIZATION; 2) UPDATE TO DISTRIBUTION CENTER SORTER TOOL (DCST) SYSTEM; 3) NEW SUPPLIER FOR GOLD PREFORM COMPONENT (BRAZING PREFORM FOR FEED-THROUGH MANUFACTURING);4) SECOND SOURCE SUPPLIER OF ANODE SUBSTRATES; 5) VAPOR DEGREASER CLEANING BACK PROLIFERATION TO LEGACY PRODUCTS; 6) NEW 3D LASER MARKER AT MJC; 7) STATEK CRYSTAL WITH PRE-PLATED CERAMIC BASE STATEK CRYSTAL WITH PRE-PLATED CERAMIC BASE;8) ALTERNATIVE UV IRRADIATION EQUIPMENT FOR DIEPREP AREA; AND 9) MODIFICATION OF M017/M019 PROBE 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