BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Coronary Drug-Eluting Stent

    PMA: P020026 · Supplement: S003 · Decision Oct 10, 2003
    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
    S003
    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
    October 10, 2003
    Date Received
    June 23, 2003
    Supplement Type
    Real-Time Process
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE ADDITION OF A SECOND IDENTITY METHOD FOR RAPAMYCIN IN CYPHER SIROLIMUS-ELUTING CORONARY STENTS. THIS METHOD WILL BE PERFORMED IN CONJUNCTION WITH THE CURRENTLY APPROVED IDENTITY METHOD. THE ADDITION OF THE SECOND IDENTITY METHOD IS IN ACCORDANCE WITH ONE OF THE CONDITIONS OF APPROVAL COMMITMENTS MADE FOR THIS PMA.

    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