BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Absorbable Coronary Drug-Eluting Stent

    PMA: P150023 · Supplement: S003 · Decision Oct 10, 2017
    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
    S003
    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 10, 2017
    Date Received
    August 5, 2016
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Postapproval Study Protocol - OSB
    Expedited Review
    N

    Advisory Committee Statement

    Approval for your premarket approval application (PMA) request that we place your study on hold.

    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