BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    System, Esophageal Pacing

    PMA: P840002 · Supplement: S013 · Decision Mar 24, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1

    Basic Information

    Device Name
    System, Esophageal Pacing
    Trade Name
    TAP SYSTEM 2A
    PMA Number
    P840002
    Supplement Number
    S013
    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 24, 2016
    Date Received
    May 28, 2015
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Location Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Approval for a manufacturing site located at Cardiocommand, Inc., in Tampa, Florida, for the manufacture of the Tapsystem Model 2A device.

    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