BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Coronary Drug-Eluting Stent

    PMA: P030025 · Supplement: S002 · Decision May 5, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    32
    Registration Numbers
    32

    Basic Information

    Device Name
    Coronary Drug-Eluting Stent
    Trade Name
    TAXUS EXPRESS2 MONORAIL AND OVER-THE-WIRE CORONARY STENT SYSTEMS
    PMA Number
    P030025
    Supplement Number
    S002
    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 5, 2004
    Date Received
    April 5, 2004
    Supplement Type
    Special (Immediate Track)
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL TO IMPLEMENT THE FOLLOWING: 1) THE ADDITION OF AN ADDITIONAL IN-PROCESS INSPECTION, 2) MODIFICATION OF A CURRENT IN-PROCESS INSPECTION, AND 3) MODIFICATION OF A MANUFACTURING PROCESS TO ADDRESS COMPLAINTS RELATED TO FAILURE OF THE DELIVERY SYSTEM BALLOON TO PROPERLY DEFLATE FOLLOWING STENT DEPLOYMENT.

    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