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

    Gastric Emptying Breath Test

    PMA: P110015 · Supplement: S004 · Decision Jul 12, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2

    Basic Information

    Device Name
    Gastric Emptying Breath Test
    Trade Name
    13 C-SPIRULINA GASTRIC EMPTYING BREATH TEST (GEBT)
    PMA Number
    P110015
    Supplement Number
    S004
    Device Class
    FDA Class 3
    Product Code
    PGE
    Generic Name
    Gastric Emptying Breath Test
    Medical Specialty
    Unknown
    Advisory Committee
    Clinical Chemistry
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    July 12, 2018
    Date Received
    June 14, 2018
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Software and system upgrade to the analytical system used to test solid samples of Cairn’s drug substance. The drug is a component of the 13C-Spirulina gastric emptying breath test (GEBT).

    Classifications

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

    Product Code Device Name
    PGE Gastric Emptying Breath Test