BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stent, Coronary

    PMA: P970020 · Supplement: S024 · Decision Jun 23, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28

    Basic Information

    Device Name
    Stent, Coronary
    Trade Name
    ACS MULTI-LINK RX DUET (TM)/ACS MULTI-LINK OTW DUET CORONARY STENT SYSTEMS
    PMA Number
    P970020
    Supplement Number
    S024
    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
    June 23, 2000
    Date Received
    May 30, 2000
    Supplement Type
    Real-Time Process
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR INCLUSION OF THE SIX-MONTH CLINICAL TRIAL DATA FROM THE DUET STUDY IN THE INSTRUCTIONS FOR USE (IFU) FOR THE ACS MULTI-LINK RX AND OTW DUET(TM) CORONARY STENT SYSTEMS.

    Classifications

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

    Product Code Device Name
    MAF Stent, Coronary