BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    System, Esophageal Pacing

    PMA: P860008 · Supplement: S019 · Decision Aug 18, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1

    Basic Information

    Device Name
    System, Esophageal Pacing
    Trade Name
    CARDIOCOMMAND ESOPHAGEAL BIPOLAR PACING & RECORDING CATHETERS
    PMA Number
    P860008
    Supplement Number
    S019
    Device Class
    FDA Class 3
    Product Code
    LPA
    Generic Name
    SYSTEM, ESOPHAGEAL PACING
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    August 18, 2009
    Date Received
    July 6, 2009
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR MODIFICATION OFF THE LABELING TO ENHANCE THE SAFETY IN THE USE OF THE PRODUCTS.

    Classifications

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

    Product Code Device Name
    LPA System, Esophageal Pacing