BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Defibrillator, Implantable, Dual-Chamber

    PMA: P050023 · Supplement: S014 · Decision Jul 1, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6

    Basic Information

    Device Name
    Defibrillator, Implantable, Dual-Chamber
    Trade Name
    COROX OTW UP STEROID-ELUTING LEAD
    PMA Number
    P050023
    Supplement Number
    S014
    Device Class
    FDA Class 3
    Product Code
    MRM
    Generic Name
    DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    July 1, 2011
    Date Received
    June 4, 2008
    Supplement Type
    135 Review Track For 30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A SECOND MANUFACTURER OF THE STEROID COLLAR, AND SECOND SOURCE OF DEXAMETHASONE ACETATE (DXA) USED FOR PRODUCTION OF THE STEROID COLLAR.

    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