BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stent, Coronary

    PMA: P020047 · Decision Jul 16, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28

    Basic Information

    Device Name
    Stent, Coronary
    Trade Name
    MULTI-LINK VISION/MINI/8 CORONARY STENT SYSTEMS
    PMA Number
    P020047
    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
    July 16, 2003
    Date Received
    October 21, 2002
    Expedited Review
    N
    Docket Number
    03M-0499

    Advisory Committee Statement

    APPROVAL FOR THE MULTI-LINK RX AND OTW VISION CORONARY STENT SYSTEMS (CSS). THESE DEVICES ARE INDICATED FOR IMPROVING CORONARY LUMINAL DIAMETER IN THE FOLLOWING:1) PATIENTS WITH SYMPTOMATIC ISCHEMIC HEART DISEASE DUE TO DISCRETE DE NOVO OR RESTENOTIC NATIVE CORONARY ARTERY LESIONS (LENGTH <25 MM) WITH REFERENCE VESSEL DIAMETERS RANGING FROM 3.0 MM TO 4.0 MM. 2) PATIENTS WITH SYMPTOMATIC ISCHEMIC HEART DISEASE DUE TO LESIONS IN SAPHENOUS VEIN BYPASS GRAFTS (LENGTH <25 MM) WITH REFERENCE VESSEL DIAMETERS RANGING FROM 3.0 MM TO 4.0 MM 3) RESTORING CORONARY FLOW IN PATIENTS EXPERIENCING ACUTE MYOCARDIAL INFARCTION, AS CONFIRMED BY ST SEGMENT ELEVATION OR ANGIOGRAPHIC FINDINGS, WHO PRESENT WITHIN 12 HOURS OF SYMPTOM ONSET WITH NATIVE CORONARY ARTERY LESIONS OF LENGTH <25 MM WITH A REFERENCE VESSEL DIAMETER OF 3.0 MM TO 4.0 MM. OUTCOME (BEYOND 9 MONTHS) FOR THIS PERMANENT IMPLANT IS UNKNOWN AT PRESENT.

    Classifications

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

    Product Code Device Name
    MAF Stent, Coronary