BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    System, Esophageal Pacing

    PMA: P860008 · Supplement: S001 · Decision Mar 17, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1

    Basic Information

    Device Name
    System, Esophageal Pacing
    Trade Name
    ARZCO TRANSESOPHAGEAL CARDIAC STIMULATOR MODEL 7
    PMA Number
    P860008
    Supplement Number
    S001
    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
    March 17, 1988
    Date Received
    August 5, 1987
    Supplement Type
    Panel Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    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