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    FDA PMA FDA Class 3 Approved (Withdrawn) 🇺🇸 United States

    Stent, Coronary

    PMA: P030037 · Decision Apr 29, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28

    Basic Information

    Device Name
    Stent, Coronary
    Trade Name
    RITHRON-XR CORONARY STENT SYSTEM
    PMA Number
    P030037
    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    Approved (Withdrawn)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
    April 29, 2005
    Date Received
    September 2, 2003
    Expedited Review
    N
    Docket Number
    05M-0193

    Advisory Committee Statement

    APPROVAL FOR THE RITHRON-XR CORONARY STENT SYSTEM. THE DEVICE IS INDICATED FOR USE IN PATIENTS ELIGIBLE FOR BALLOON ANGIOPLASTY WITH SYMPTOMATIC ISCHEMIC HEART DISEASE CHARACTERIZED BY DISCRETE DE NOVO CORONARY ARTERY LESIONS WITH REFERENCE VESSEL DIAMETER FROM >=3.0 MM OR <=4.0 MM AND TARGET LESION LENGTH <=20.0 MM.

    Classifications

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

    Product Code Device Name
    MAF Stent, Coronary