BEUDAMED
    FDA PMA FDA Class 3 30-Day Notice Accepted 🇺🇸 United States

    Heart-Valve, Mechanical

    PMA: P990046 · Supplement: S035 · Decision Aug 7, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    17
    Registration Numbers
    17

    Basic Information

    Device Name
    Heart-Valve, Mechanical
    Trade Name
    OPEN PIVOT HEART VALVE AND OPEN PIVOT AORTIC VALVE GRAFT
    PMA Number
    P990046
    Supplement Number
    S035
    Device Class
    FDA Class 3
    Product Code
    LWQ
    Generic Name
    HEART-VALVE, MECHANICAL
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    August 7, 2013
    Date Received
    July 8, 2013
    Supplement Type
    30-Day Notice
    Expedited Review
    N

    Advisory Committee Statement

    REVIEW OF: 1) INSTALLATION QUALIFICATION (IQ) REPORTS FOR 4 PIECES OF EQUIPMENTRELATED TO AN ALREADY APPROVED SITE CHANGE SUPPLEMENT; AND 2) ONE PROCESS QUALIFICATION (PQ) REPORT FOR ONE PIECE OF EQUIPMENT RELATED TO AN ALREADY APPROVED SITE CHANGE SUPPLEMENT. THESE CHANGES APPLY TO THE OPEN PIVOT HEART VALVE AND OPEN PIVOT AORTIC VALVED GRAFT.

    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