BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Absorbable Coronary Drug-Eluting Stent

    PMA: P150023 · Supplement: S001 · Decision Oct 7, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2

    Basic Information

    Device Name
    Absorbable Coronary Drug-Eluting Stent
    Trade Name
    ABSORB GT1 BIORESORBABLE VASCULAR SCAFFOLD (BVS) SYSTEM
    PMA Number
    P150023
    Supplement Number
    S001
    Device Class
    FDA Class 3
    Product Code
    PNY
    Generic Name
    Absorbable coronary drug-eluting stent
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    October 7, 2016
    Date Received
    July 11, 2016
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for a shelf life extension from 12 months to 18 months for the small scaffold design (2.5 and 3.0mm diameters), and the implementation of an alternate temperature monitoring system.

    Classifications

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

    Product Code Device Name
    PNY Absorbable Coronary Drug-Eluting Stent