BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stent, Coronary

    PMA: P900043 · Supplement: S038 · Decision Aug 2, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28

    Basic Information

    Device Name
    Stent, Coronary
    Trade Name
    BX SONIC BALLOON EXPANDABLE STENT OTW DELIVERY SYSTEM
    PMA Number
    P900043
    Supplement Number
    S038
    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
    August 2, 2002
    Date Received
    February 25, 2002
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A MODIFICATION OF THE INDICATIONS FOR THE BX SONIC BALLOON-EXPANDABLE STENT OTW DELIVERY SYSTEM. THE DEVICE, AS MODIFIED, IS INDICATED FOR IMPROVING CORONARY LUMINAL DIAMETER IN THE FOLLOWING: 1) FOR TREATMENT OF PATIENTS WITH SYMPTOMATIC ISCHEMIC HEART DISEASE DUE TO DISCRETE DE NOVO OR RESTENOTIC LESIONS (<=30 MM IN LENGTH) IN NATIVE CORONARY ARTERIES WITH REFERENCE DIAMETERS RANGING FROM 3.0 MM TO 5.0 MM INVOLVING DIRECT STENTING OR PREDILATATION; AND 2) FOR TREATMENT OF ABRUPT OR THREATENED VESSEL CLOSURE IN PATIENTS WITH FAILED INTERVENTIONAL THERAPY IN LESIONS (<=30 MM IN LENGTH) WITH REFERENCE DIAMETERS IN THE RANGE OF 2.25 MM TO 4.0 MM. THE 2.25 MM, 2.5 MM, AND 2.75 MM DIAMETERS ARE SOLELY INDICATED FOR USE IN PATIENTS WITH ABRUPT OR THREATENED CLOSURE, AND THE 4.5 AND 5.0 MM DIAMETERS ARE INDICATED SOLELY FOR USE IN PATIENTS WITH SYMPTOMATIC ISCHEMIC HEART DISEASE DUE TO DISCRETE DE NOVO OR RESTENOTIC LESIONS.

    Classifications

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

    Product Code Device Name
    MAF Stent, Coronary