BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Heart-Valve, Mechanical

    PMA: P790018 · Supplement: S041 · Decision Apr 23, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    17
    Registration Numbers
    17

    Basic Information

    Device Name
    Heart-Valve, Mechanical
    Trade Name
    MEDTRONIC HALL AORTIC VALVED COLLAGEN IMPREGNATED CONDUIT, MODEL Z7700, AND MEDTRONIC HALL ROTATABLE AORTIC VALVED COLL0
    PMA Number
    P790018
    Supplement Number
    S041
    Device Class
    FDA Class 3
    Product Code
    LWQ
    Generic Name
    HEART-VALVE, MECHANICAL
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    April 23, 2002
    Date Received
    November 19, 2001
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A CHANGE TO THE COUNTRY OF ORIGIN FOR THE COLLAGEN USED IN THESE PRODUCTS. THE INTENT OF THE CHANGE IS TO SOURCE THE COLLAGEN FROM A COUNTRY THAT IS FREE FROM BOVINE SPONGIFORM ENCEPHALOPATHY (BSE).

    Classifications

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

    Product Code Device Name
    LWQ Heart-Valve, Mechanical