BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Absorbable Coronary Drug-Eluting Stent

    PMA: P150023 · Supplement: S002 · Decision Aug 25, 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
    S002
    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
    August 25, 2016
    Date Received
    July 29, 2016
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    Approval for labeling changes to clarify the interpretation of the ABSORB III clinical data for geriatric patients in the Absorb GT1 BVS Instructions for Use.

    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