BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    System, Pacing, Temporary, Acute, Internal Atrial Defibrillation

    PMA: P990069 · Supplement: S001 · Decision Sep 29, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    System, Pacing, Temporary, Acute, Internal Atrial Defibrillation
    Trade Name
    ALERT SYSTEM-COMPANION II
    PMA Number
    P990069
    Supplement Number
    S001
    Device Class
    FDA Class 3
    Product Code
    MTE
    Generic Name
    System, pacing, temporary, acute, internal atrial defibrillation
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    September 29, 2003
    Date Received
    April 28, 2003
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE ALERT SYSTEM, COMPANION II. THE DEVICE, AS MODIFIED, IS INDICATED FOR USE IN PATIENTS WHO ARE CANDIDATES FOR TRANSVENOUS ELECTRICAL CARDIOVERSION FOR THE TREATMENT OF ATRIAL FIBRILLATION.

    Classifications

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

    Product Code Device Name
    MTE System, Pacing, Temporary, Acute, Internal Atrial Defibrillation