BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Coronary Drug-Eluting Stent

    PMA: P020026 · Supplement: S014 · Decision May 17, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    32
    Registration Numbers
    32

    Basic Information

    Device Name
    Coronary Drug-Eluting Stent
    Trade Name
    CYPHER SIROLIMUS-ELUTING CORONARY STENT ON THE RAPTOR OVER-THE-WIRE DELIVERY SYSTEM OR RAPTORRAIL RAPID EXCHANGE DELIVER
    PMA Number
    P020026
    Supplement Number
    S014
    Device Class
    FDA Class 3
    Product Code
    NIQ
    Generic Name
    Coronary drug-eluting stent
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    May 17, 2006
    Date Received
    July 18, 2005
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL TO IMPLEMENT NEW ORTHOGONAL METHODS TO QUANTITATE DRUG CONTENT, IMPURITIES AND DEGRADATION PRODUCTS FOR THE CYPHER STENT. BASED UPON THESE NEW METHODS, YOU HAVE ALSO REQUESTED APPROVAL FOR NEW SPECIFICATIONS FOR IMPURITIES AND DEGRADATION PRODUCTS FOR THE CYPHER STENT AT FINISHED GOODS RELEASE TESTING AND ON STABILITY. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME CYPHER SIROLIMUS-ELUTING CORONARY STENT ON THE RAPTOR OVER-THE-WIRE DELIVERY SYSTEM OR RAPTORRAIL RAPID EXCHANGE DELIVERY SYSTEM AND IS INDICATED FOR IMPROVING CORONARY LUMINAL DIAMETER IN PATIENTS WITH SYMPTOMATIC ISCHEMIC DISEASE DUE TO DISCRETE DE NOVO LESIONS OF LENGTH <= 30MM IN NATIVE CORONARY ARTERIES WITH REFERENCE VESSEL DIAMETER OF >= 2.5 MM TO <= 3.5 MM.

    Classifications

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

    Product Code Device Name
    NIQ Coronary Drug-Eluting Stent