BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Heart-Valve, Mechanical

    PMA: P790018 · Supplement: S043 · Decision Apr 9, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    17
    Registration Numbers
    17

    Basic Information

    Device Name
    Heart-Valve, Mechanical
    Trade Name
    MEDTRONIC HALL ROTATABLE AORTIC VALVED COLLAGEN IMPREGNATED CONDUIT
    PMA Number
    P790018
    Supplement Number
    S043
    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 9, 2002
    Date Received
    March 22, 2002
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Express GMP Supplement
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR AN ALTERNATE MANUFACTURING FACILITY LOCATED AT MEDTRONIC, SPRING LAKE PARK, MINNESOTA. MANUFACTURING OPERATIONS RELATED TO FABRICATION OF THE SEWING RING, ATTACHMENT OF THE CONDUIT AND SEWING RING TO THE DISC AND HOUSING SUBASSEMBLY, AND STERILE AND FINAL PACKAGING PROCESSES FOR THE MEDTRONIC HALL ROTATABLE AORTIC VALVED COLLAGEN IMPREGNATED CONDUIT PROSTHESIS (MODEL R7700) WILL BE PERFORMED AT THIS FACILITY.

    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