BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    System, Pacing, Temporary, Acute, Internal Atrial Defibrillation

    PMA: P020052 · Supplement: S001 · Decision Aug 22, 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
    CARDIOVERSION SWITCHBOX II SYSTEM
    PMA Number
    P020052
    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
    August 22, 2003
    Date Received
    July 15, 2003
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE CARDIOVERSION SWITCHBOX II SYSTEM. THE DEVICE IS INDICATED AS FOLLOWS: THE CARDIOVERSION SWITCHBOX II SYSTEM CONNECTS A ST. JUDE MEDICAL CARDIOVERSION (CV) CATHETER AND EXTENSION CABLE TO A COMPATIBLE CARDIOVERTER/DEFIBRILLATOR AND EP RECORDING SYSTEM.

    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