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

    Defibrillator, Implantable, Dual-Chamber

    PMA: P980049 · Supplement: S019 · Decision May 13, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6

    Basic Information

    Device Name
    Defibrillator, Implantable, Dual-Chamber
    Trade Name
    ALTO SHOCK 4 MODULES
    PMA Number
    P980049
    Supplement Number
    S019
    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 13, 2005
    Date Received
    April 13, 2005
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    CHANGES TO THE MANUFACTURING PROCESS AT INTERNATIONAL RECTIFIER, LEOMINSTER, MASSACHUSETTS AND THALES, NEUILLY-SUR-SEINE, FRANCE. THE MODIFICATIONS INCLUDE: 1) CHANGING THE EPOXY RESIN FOR ENCAPSULATION 2) REMOVING THE PARYLENE COATING 3) CHANGING THE PHOTOCOUPLER AND DISCHARGE CIRCUITS FORM SEPARATE COMPONENTS TO A SINGLE COMPONENT COATED WITH EPOXY 4) CHANGING THE EPOXY FOR ATTACHING THE TRANSFORMER, AND 5) ADDING A SILICONE COVER OVER CERTAIN CAPACITORS PRIOR TO THE FINAL ASSEMBLY 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