BEUDAMED
    FDA PMA FDA Class 3 30-Day Notice Accepted 🇺🇸 United States

    System, Pacing, Temporary, Acute, Internal Atrial Defibrillation

    PMA: P020052 · Supplement: S003 · Decision Sep 21, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    System, Pacing, Temporary, Acute, Internal Atrial Defibrillation
    Trade Name
    RESPONSE CV CARDIOVERSION ELECTROPHYSIOLOGY CATHETER
    PMA Number
    P020052
    Supplement Number
    S003
    Device Class
    FDA Class 3
    Product Code
    MTE
    Generic Name
    System, pacing, temporary, acute, internal atrial defibrillation
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    September 21, 2007
    Date Received
    August 24, 2007
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    IMPLEMENTATION OF NEWLY QUALIFIED ELECTRODE RING SWAGING EQUIPMENT AND SWAGING DIES, FOR SWAGING ELECTRODE RINGS ONTO CATHETER SHAFT, AND PERFORMANCE OF PREVENTIVE CLEANING FOR SWAGING DIES.

    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