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

    Pulse Generator, Permanent, Implantable

    PMA: P980035 · Supplement: S318 · Decision May 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
    S318
    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
    May 7, 2013
    Date Received
    April 9, 2013
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    SEVEN PREVIOUSLY APPROVED MANUFACTURE CHANGES FOR THE DEVICES. THOSE ARE:1) UPDATE THE CMOS IC PROCESS FLOW CHANGES AT YOUR SUPPLIER; 2) UPDATE THE TEST SOFTWARE AND HARDWARE ON THE TERADYNE TEST PLATFORM FOR M019 AND M017 ICS;3) ADD THE HIGH TEMPERATURE MONITOR TO HIGH POWER LEAN LINE; 4) UPDATE THE AUTOMATED ASSEMBLY EQUIPMENT CONTROLLER (AAEC); 5) IMPLEMENT A NEW CLEANING PROCESS AND A CURING OVEN; 6) IMPLEMENT A MANUFACTURING EXECUTION SYSTEM VERSION 7.9 AT VARIOUS INTERNAL SUPPLIERS AND FINAL DEVICE MANUFACTURING LOCATIONS; AND7) UPDATE TO THE TEST SYSTEM SOFTWARE SHELL.

    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