BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Heart-Valve, Non-Allograft Tissue

    PMA: P060025 · Supplement: S003 · Decision Mar 5, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19

    Basic Information

    Device Name
    Heart-Valve, Non-Allograft Tissue
    Trade Name
    ATS 3F AORTIC BIOPROSTHESIS MODEL 1000
    PMA Number
    P060025
    Supplement Number
    S003
    Device Class
    FDA Class 3
    Product Code
    LWR
    Generic Name
    heart-valve, non-allograft tissue
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    March 5, 2009
    Date Received
    January 5, 2009
    Supplement Type
    Real-Time Process
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR EXTENSION OF THE SHELF-LIFE OF THE ATS 3F AORTIC BIOPROSTHESIS, MODEL 1000 VALVES (SIZES 19, 21, 23, 25, 27 AND 29 MM) FROM 2 YEARS TO 5 YEARS. THE DEVICE IS INDICATED FOR ¿..USE IN PATIENTS WHOSE AORTIC VALVULAR DISEASE IS SUFFICIENTLY ADVANCED TO WARRANT REPLACEMENT OF THEIR VALVE WITH A PROSTHETIC DEVICE. THE USUAL CONDITIONS OF ADVANCED DISEASE INCLUDE AORTIC STENOSIS, AORTIC INCOMPETENCE, AND A COMBINATION OF THE TWO.¿

    Classifications

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

    Product Code Device Name
    LWR Heart-Valve, Non-Allograft Tissue