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    FDA PMA FDA Class 3 Approved (Withdrawn) 🇺🇸 United States

    Stent, Coronary

    PMA: P000011 · Decision Sep 29, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28

    Basic Information

    Device Name
    Stent, Coronary
    Trade Name
    BIODIVYSIO AS PS (PHOSPHORYLCHOLINE)COATED STENT DELIVERY SYSTEM
    PMA Number
    P000011
    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    Approved (Withdrawn)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 29, 2000
    Date Received
    February 25, 2000
    Expedited Review
    N
    Docket Number
    01M-0055

    Advisory Committee Statement

    APPROVAL FOR THE BIODIVYSIO(TM) AS PC (PHOSPHORYLCHOLINE) COATED STENT AND DELIVERY SYSTEM. THE DEVICE IS INTENDED FOR USE IN SUBJECTS WITH SYMPTOMATIC ISCHEMIC HEART DISEASE DUE TO DE NOVO NATIVE CORONARY ARTERY LESIONS (LENGTH <= 25 MM) WITH A REFERENCE VESSEL DIAMETER RANGING FROM >= 3.0 MM TO <= 4.0 MM AND INTENDED TO IMPROVE CORONARY LUMINAL DIAMETER. LONG TERM OUTCOME (BEYOND SIX 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