BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Defibrillator, Implantable, Dual-Chamber

    PMA: P980049 · Supplement: S010 · Decision Oct 14, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6

    Basic Information

    Device Name
    Defibrillator, Implantable, Dual-Chamber
    Trade Name
    ORCHESTRA PROGRAMMER
    PMA Number
    P980049
    Supplement Number
    S010
    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
    October 14, 2003
    Date Received
    September 11, 2003
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR MODIFICATIONS TO THE PROGRAMMING HEAD OF THE ORCHESTRA PROGRAMMER, INCLUDING THE ADDITION OF HIGH-SPEED TELEMETRY AND OTHER CHANGES. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME CPR3 PROGRAMMING HEAD AND IS INDICATED FOR USE WITH THE ORCHESTRA DEDICATED PROGRAMMER TO INTERROGATE AND PROGRAM ELA MEDICAL PULSE GENERATORS VIA BI-DIRECTIONAL TELEMETRY.

    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