BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    System, Esophageal Pacing

    PMA: P860008 · Supplement: S017 · Decision Feb 3, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1

    Basic Information

    Device Name
    System, Esophageal Pacing
    Trade Name
    TAPCATH AND TAPSCOPE DISPOSABLE TRANSESOPHAGEAL PROBES
    PMA Number
    P860008
    Supplement Number
    S017
    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
    February 3, 2005
    Date Received
    January 16, 2004
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Express GMP Supplement
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A MANUFACTURING SITE AT CARDIOCOMMAND, INC., TAMPA, FLORIDA.

    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