BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Coronary Drug-Eluting Stent

    PMA: P060008 · Supplement: S008 · Decision May 21, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    32
    Registration Numbers
    32

    Basic Information

    Device Name
    Coronary Drug-Eluting Stent
    Trade Name
    TAXUS LIBERTE ATOM PACLITAXEL-ELUTING CORONARY STENT SYSTEM
    PMA Number
    P060008
    Supplement Number
    S008
    Device Class
    FDA Class 3
    Product Code
    NIQ
    Generic Name
    Coronary drug-eluting stent
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    May 21, 2009
    Date Received
    November 28, 2008
    Supplement Type
    Panel Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N
    Docket Number
    09M-0255

    Advisory Committee Statement

    APPROVAL TO EXPAND THE PRODUCT MATRIX TO INCLUDE THE 2.25 MM TAXUSLIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM. THIS DEVICE SIZE WILL BE MARKETED UNDER THETRADE NAME TAXUS LIBERTE ATOM PACLITAXEL-ELUTING CORONARY STENT SYSTEM (MONORAIL AND OVER-THE-WIRE DELIVERY SYSTEMS), AND IS INDICATED FOR IMPROVING LUMINAL DIAMETER FOR THETREATMENT OF DE NOVO LESIONS IN NATIVE CORONARY ARTERIES > =2.25 MM TO <= 4.00 MM IN DIAMETER INLESIONS <= 28 MM IN LENGTH.

    Classifications

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

    Product Code Device Name
    NIQ Coronary Drug-Eluting Stent