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

    Defibrillator, Implantable, Dual-Chamber

    PMA: P980049 · Supplement: S074 · Decision May 30, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6

    Basic Information

    Device Name
    Defibrillator, Implantable, Dual-Chamber
    Trade Name
    PARADYM RF VR & RF DR ICD
    PMA Number
    P980049
    Supplement Number
    S074
    Device Class
    FDA Class 3
    Product Code
    MRM
    Generic Name
    DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    May 30, 2012
    Date Received
    May 16, 2012
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    THE FOLLOWING CHANGES: 1) AN ALTERNATE REFLOW OVEN WITH AN UPDATED REFLOW SOLDERING PROFILE AND AN ALTERNATE COMPONENT CARRIER; 2) AN UPDATE TO THE REWORK PROCESS; 3) IN-SOURCING OF AN ELECTRONIC ASSEMBLY; 4) CLEAN ROOM LAYOUT MODIFICATION AT SALUGGIA, ITALY, PLANT, AND; 5)AN ALTERNATE METHOD FOR A HYBRID MODULE WIRE BONDING PROCESS.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MRM Defibrillator, Implantable, Dual-Chamber