BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stent, Coronary

    PMA: P970035 · Supplement: S033 · Decision Apr 24, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28

    Basic Information

    Device Name
    Stent, Coronary
    Trade Name
    S7 WITH DISCRETE TECHNOLOGY OVER THE WIRE CORONARY STENT SYSTEM
    PMA Number
    P970035
    Supplement Number
    S033
    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
    April 24, 2002
    Date Received
    December 26, 2001
    Supplement Type
    135 Review Track For 30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE ADDITION OF AN OPTIONAL MECHANICAL FIXATION STEP TO THE STENT SECUREMENT PROCESS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME S7 WITH DISCRETE TECHNOLOGY OVER-THE-WIRE CORONARY STENT SYSTEM AND IS INDICATED FOR THE IMPROVEMENT OF CORONARY LUMINAL DIAMETER.

    Classifications

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

    Product Code Device Name
    MAF Stent, Coronary