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

    System, Pacing, Temporary, Acute, Internal Atrial Defibrillation

    PMA: P020052 · Supplement: S008 · Decision Oct 13, 2011
    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 & SYSTEM ACCESSORY EQUIPMENT
    PMA Number
    P020052
    Supplement Number
    S008
    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
    October 13, 2011
    Date Received
    September 15, 2011
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    ELIMINATE THE UV POST TRIM PROCESS.

    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