BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stent, Coronary

    PMA: P970035 · Supplement: S022 · Decision Apr 4, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28

    Basic Information

    Device Name
    Stent, Coronary
    Trade Name
    S7 WITH DISCRETE TECHNOLOGY(TM) OVER-THE-WIRE/RAPID EXCHANGE CORONARY STENT SYSTEM
    PMA Number
    P970035
    Supplement Number
    S022
    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 4, 2001
    Date Received
    October 20, 2000
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE S7 WITH DISCRETE TECHNOLOGY(TM) OVER-THE-WIRE (OTW) AND RAPID EXCHANGE (RZ) CORONARY STENT SYSTEMS. THE DEVICES ARE INDICATED FOR IMPROVING CORONARY LUMINAL DIAMETER IN PATIENTS WITH SYMPTOMATIC ISCHEMIC HEART DISEASE DUE TO DE NOVO LESIONS (LENGTH <= 30 MM) IN NATIVE CORONARY ARTERIES WITH REFERENCE VESSEL DIAMETERS RANGING FROM 3.0 MM AND 4.0 MM. LONG TERM OUTCOME (BEYOND 14 DAYS) FOR THIS PERMANENT IMPLANT IS UNKNOWN AT PRESENT. THE RX RELIVERY SYSTEM WILL ALLOW FOR PERFUSION AT AN AVERAGE RATE OF 2 CC/MIN AT NOMINAL PRESSURE DURING THE 15-30 SECOND STENT DEPLOYMENT PROCEDURE ONLY THE RAPID EXCHANGE STENT DELIVERY SYSTEM IS NOT INTENDED FOR USE AS A STAND ALONE PTCA PERFUSION CATHETER.

    Classifications

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

    Product Code Device Name
    MAF Stent, Coronary