BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stent, Coronary

    PMA: P000011 · Supplement: S004 · Decision Mar 1, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28

    Basic Information

    Device Name
    Stent, Coronary
    Trade Name
    BIODIVYSIO OC/OTW STENT SYSTEM
    PMA Number
    P000011
    Supplement Number
    S004
    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
    March 1, 2002
    Date Received
    August 31, 2001
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE BIODIVYSIO OC OTW IN 11 MM, 15 MM, 18 MM, 22 MM AND 28 MM STENT LENGTHS AND 3.0 MM, 3.5 MM AND 4.0 MM DIAMETERS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME BIODIVYSIO OC OTW AND IS INDICATED FOR: "USE IN SUBJECTS WITH SYMPTOMATIC ISCHEMIC HEART DISEASE DUE TO DE NOVO NATIVE CORONARY ARTERY LESIONS (LENGTH <= 25 MM) WITH A REFERENCE VESSEL DIAMETER RANGING FROM >= 3.0 MM TO <= 4.0 MM AND INTENDED TO IMPROVE CORONARY LUMINAL DIAMETER. LONG-TERM OUTCOME (BEYOND 6 MONTHS) FOR THIS 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