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

    Heart-Valve, Mechanical

    PMA: P900060 · Supplement: S017 · Decision Jun 11, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    17
    Registration Numbers
    17

    Basic Information

    Device Name
    Heart-Valve, Mechanical
    Trade Name
    SULZER CARBOMEDICS CARBO-SEAL ASCENDING AORTIC PROSTHESIS
    PMA Number
    P900060
    Supplement Number
    S017
    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
    June 11, 1998
    Date Received
    June 1, 1998
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Requested a modification in the type of biological indicator used in the sterility release of the Carbo-Seal AAP from the AMSCO Spordex Bacillus subtilis globigii spore strips to the 3M Healthcare Attest Bacillus subtilis globigii self-contained biological indicator. The stzated reason for the change is to reduce the incubation period from seven to two days, and to reduce the change of operator error by eliminating the possibilitry of contaimination that may occur when spore strips in glassine envelopes are transferred to growth medium.

    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