BEUDAMED
    FDA PMA FDA Class 3 Approved (Withdrawn) 🇺🇸 United States

    Stent, Coronary

    PMA: P020009 · Decision Sep 11, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28

    Basic Information

    Device Name
    Stent, Coronary
    Trade Name
    EXPRESS/EXPRESS 2 MR & OTW CORONARY STENT SYSTEMS
    PMA Number
    P020009
    Device Class
    FDA Class 3
    Product Code
    MAF
    Generic Name
    STENT, CORONARY
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved (Withdrawn)
    Decision Code
    APWD
    Decision Date
    September 11, 2002
    Date Received
    March 15, 2002
    Expedited Review
    N
    Docket Number
    03M-0116

    Advisory Committee Statement

    APPROVAL FOR THE EXPRESS AND EXPRESS2 MONORAIL AND OVER-THE-WIRE CORONARY STENT SYSTEMS. THESE DEVICES ARE INDICATED FOR IMPROVING CORONARY LUMINAL DIAMETER IN THE FOLLOWING: 1) PATIENTS WITH SYMPTOMATIC ISCHEMIC DISEASE ASSOCIATED WITH STENOTIC LESIONS IN NATIVE CORONARY ARTERIES (LENGTH < 18 MM) WITH A REFERENCE VESSEL DIAMETER OF 3.0 TO 5.0 MM. 2) TREATMENT OF ABRUPT OR THREATENED ABRUPT CLOSURE (AC/TAC) IN PATIENTS WITH FAILED INTERVENTIONAL THERAPY IN LESIONS IN NATIVE CORONARY ARTERIES OF 2.25 TO 5.0 MM (INCLUSIVE) IN DIAMETER AND < 30 MM LONG. LONG-TERM OUTCOME (BEYOND 6 MONTHS) FOR THIS PERMANENT 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