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

    Pulse Generator, Permanent, Implantable

    PMA: P980035 · Supplement: S308 · Decision Mar 7, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    35
    Registration Numbers
    35

    Basic Information

    Device Name
    Pulse Generator, Permanent, Implantable
    Trade Name
    ADVISA MRI
    PMA Number
    P980035
    Supplement Number
    S308
    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
    March 7, 2013
    Date Received
    February 7, 2013
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    MULTIPLE MANUFACTURING CHANGES PREVIOUSLY ACCEPTED FOR OTHER MARKET RELEASED MEDTRONIC DEVICES, WHICH INCLUDED: 1) CMOS PROCESS FLOW CHANGES AT YOUR SUPPLIER; 2) UPDATES TO THE TEST SOFTWARE AND HARDWARE FOR INTEGRATED CIRCUITS; 3) ADDITION OF HIGH TEMPERATURE MONITORING TO THE HIGH POWER LEAN LINE; 4) UPDATE TO A MANUFACTURING ASSEMBLY CONTROLLER SYSTEM; 5) IMPLEMENTATION OF A NEW CLEANING PROCESS AND CURING OVEN; AND 6) AND IMPLEMENTATION OF THE MANUFACTURING EXECUTION SYSTEM VERSION 7.9 AT VARIOUS INTERNAL SUPPLIERS AND FINAL DEVICE MANUFACTURING LOCATIONS.

    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