BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stent, Coronary

    PMA: P020009 · Supplement: S015 · Decision May 5, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28

    Basic Information

    Device Name
    Stent, Coronary
    Trade Name
    EXPRESS2 MONORAIL AND OVER-THE-WIRE CORONARY STENT SYSTEMS
    PMA Number
    P020009
    Supplement Number
    S015
    Device Class
    FDA Class 3
    Product Code
    MAF
    Generic Name
    STENT, CORONARY
    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)
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    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
    MAF Stent, Coronary