BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stent, Coronary

    PMA: P970035 · Supplement: S036 · Decision Sep 13, 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/S7 WITH DISCRETE TECHNOLOGY RAPID EXCHANGE CORONARY
    PMA Number
    P970035
    Supplement Number
    S036
    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
    September 13, 2002
    Date Received
    March 25, 2002
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE FOLLOWING EXPANDED DEVICE INDICATIONS: THE S7 WITH DISCRETE TECHNOLOGY OVER-THE-WIRE CORONARY STENT SYSTEM WITH THE AV 2000 BALLOON IS INDICATED FOR: "IMPROVING CORONARY LUMINAL DIAMETER IN PATIENTS WITH SYMPTOMATIC ISCHEMIC HEART DISEASE DUE TO DISCRETE DE NOVO LESIONS (LENGTH <= 30 MM) IN NATIVE CORONARY ARTERIES WITH REFERENCE VESSEL DIAMETERS RANTING FROM 3.0 MM TO 4.0 MM THROUGH DIRECT STENTING OR PREDILATATION. LONG-TERM OUTCOME (BEYOND 180-DAYS) FOR THIS PERMANENT IMPLANT IS UNKNOWN AT PRESENT." THE S7 WITH DISCRETE TECHNOLOGY OVER-THE-WIRE CORONARY STENT SYSTEM WITH THE AV100 BALLOON IS INDICATED FOR: "IMPROVING CORONARY LUMINAL DIAMETER IN PATIENTS WITH SYMPTOMATIC ISCHEMIC HEART DISEASE DUE TO DISCRETE DE NOVO LESIONS (LENGTH <= 30 MM) IN NATIVE CORONARY ARTERIES WITH REFERENCE VESSEL DIAMETERS RANGING FROM 3.0 MM TO 4.0 MM THROUGH DIRECT STENTING OR PREDILATATION. LONG-TERM OUTCOME (BEYOND 180 DAYS) FOR THIS PERMANENT IMPLANT IS UNKNOWN AT PRESENT." THE S7 WITH DISCRETE TECHNOLOGY RAPID EXCHANGE CORONARY STENT SYSTEM WITH THE AV2000 BALLOON IS INDICATED FOR: "IMPROVING CORONARY LUMINAL DIAMETER IN PATIENTS WITH SYMPTOMATIC ISCHEMIC HEART DISEASE DUE TO DISCRETE DE NOVO LESIONS (LENGTH <= 30 MM) IN NATIVE CORONARY ARTERIES WITH REFERENCE VESSEL DIAMETERS RANGING FROM 3.0 MM TO 4.0 MM THROUGH DIRECT STENTING PREDILATATION. LONG-TERM OUTCOME (BEYOND 180 DAYS) FOR THIS PERMANENT IMPLANT IS UNKNOWN AT PRESENT. THE RAPID EXCHANGE DELIVERY 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." THE S7 WITH DISCRETE TECHNOLOGY RAPID EXCHANGE CORONARY STENT SYSTEM WITH THE AV100 BALLOON IS INDICATED FOR: "IMPROVING CORONARY LUMINAL DIAMETER IN PATIENTS WITH SYMPTOMATIC ISCHEMIC HEART DISEASE DUE TO DISCRETE DE NOVO LESIONS (LENGTH <= MM) IN...

    Classifications

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

    Product Code Device Name
    MAF Stent, Coronary