BEUDAMED
    FDA PMA FDA Class 3 Approved (Withdrawn) 🇺🇸 United States

    System, Pacing, Temporary, Acute, Internal Atrial Defibrillation

    PMA: P990069 · Decision Nov 27, 2002
    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 (ALERT CATHETER, ALERT INTERFACE CABLE, AND ALERT COMPANION WITH SOFTWARE VERSION 1.08)
    PMA Number
    P990069
    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    Approved (Withdrawn)
    Decision Code
    APWD
    Decision Date
    November 27, 2002
    Date Received
    November 1, 1999
    Expedited Review
    Y
    Docket Number
    03M-0240

    Advisory Committee Statement

    APPROVAL FOR THE ALERT SYSTEM (ALERT CATHETER, ALERT INTERFACE CABLE, AND ALERT COMPANION WITH SOFTWARE VERSION 1.08). THE ALERT SYSTEM 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