BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Coronary Drug-Eluting Stent

    PMA: P030025 · Supplement: S028 · Decision Sep 24, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    32
    Registration Numbers
    32

    Basic Information

    Device Name
    Coronary Drug-Eluting Stent
    Trade Name
    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM (MONORAIL AND OVER -THE-WIRE)
    PMA Number
    P030025
    Supplement Number
    S028
    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
    September 24, 2008
    Date Received
    March 13, 2006
    Supplement Type
    Panel Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N
    Docket Number
    08M-0547

    Advisory Committee Statement

    APPROVAL FOR THE TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM ¿ IN-STENT RESTENOSIS (ISR) INDICATION. THE DEVICE IS INDICATED FOR IMPROVING LUMINAL DIAMETER FOR THE TREATMENT OF DE NOVO LESIONS IN NATIVE CORONARY ARTERIES >=2.25 TO <=4.00 MM IN DIAMETER IN LESIONS <=28 MM IN LENGTH, AND WITHIN BARE METAL STENT RESTENOTIC LESIONS >=2.25 TO <=3.75 MM IN DIAMETER AND <=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