BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Replacement Heart-Valve

    PMA: P870078 · Supplement: S008 · Decision Sep 20, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11

    Basic Information

    Device Name
    Replacement Heart-Valve
    Trade Name
    HANCOCK APICAL LEFT VENTRICLE CONNECTOR
    PMA Number
    P870078
    Supplement Number
    S008
    Device Class
    FDA Class 3
    Product Code
    DYE
    Generic Name
    replacement Heart-valve
    Regulation Number
    870.3925
    Medical Specialty
    Cardiovascular
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    September 20, 2010
    Date Received
    March 31, 2010
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE HANCOCK APICAL LEFT VENTRICLE CONNECTOR, MODEL 174A. THE DEVICE IS INDICATED FOR PROVIDING AN ALTERNATIVE METHOD FOR RELIEF OF LEFT VENTRICULARHYPERTENSION IN PATIENTS WITH SEVERE LEFT VENTRICULAR OUTFLOW TRACT OBSTRUCTION DUE TO HYPOPLASIA OFTHE AORTIC ROOT, HYPOPLASIA OF THE AORTIC ANNULUS, OR ACQUIRED PROBLEMS SECONDARY TO AORTIC VALVE REPLACEMENT WHICH CANNOT BE RELIEVED THROUGH CONVENTIONAL TECHNIQUES.

    Classifications

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

    Product Code Device Name
    DYE Replacement Heart-Valve