BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stent, Coronary

    PMA: P970020 · Supplement: S023 · Decision Oct 3, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28

    Basic Information

    Device Name
    Stent, Coronary
    Trade Name
    MULTI-LINK RX TETRA(TM) CORONARY STENT SYSTEM/ MULTI-LINK OTW TETRA(TM) CORONARY STENT SYSTEM
    PMA Number
    P970020
    Supplement Number
    S023
    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
    October 3, 2000
    Date Received
    April 12, 2000
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE ACS MULTI-LINK RX AND OTW TETRA(TM) CORONARY STENT SYSTEMS. THE DEVICES ARE INDICATED FOR IMPROVING CORONARY LUMEN DIAMETER IN THE FOLLOWING: 1) PATIENTS WITH SYMPTOMATIC ISCHEMIC DISEASE DUE TO DISCRETE DE NOVO OR RESTENOTIC NATIVE CORONARY ARTERY LESIONS (LENGTH <= 25 MM) WITH A REFERENCE VESSEL DIAMETER OF 3.0 MM TO 4.0 MM; AND 2) TREATMENT OF ABRUPT OR THREATENED ABRUPT CLOSURE IN PATIENTS WITH FAILED INTERVENTIONAL THERAPY IN LESIONS (<= 35 MM IN LENGTH) WITH REFERENCE DIAMETERS IN THE RANGE OF 2.5 MM TO 4.0 MM. LONG TERM OUTCOME FOR THIS PERMANENT IMPLANT IS UNKNOWN AT PRESENT. NOTE: THE 2.5 MM AND 2.75 MM DIAMETER STENTS AND THE 33 MM AND 38 MM LENGTH STENTS ARE SOLELY INDICATED FOR USE IN PATIENTS WITH ABRUPT OR THREATENED ABRUPT CLOSURE.

    Classifications

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

    Product Code Device Name
    MAF Stent, Coronary