BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Replacement Heart-Valve

    PMA: P860057 · Supplement: S022 · Decision Jan 26, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11

    Basic Information

    Device Name
    Replacement Heart-Valve
    Trade Name
    PERIMOUNT PERICARDIAL BIOPROSTHESIS, MODELS 2700, 2800 (PERIMOUNT RSR), 6900P (PERIMOUNT PLUS) AND 3000
    PMA Number
    P860057
    Supplement Number
    S022
    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
    January 26, 2004
    Date Received
    June 20, 2003
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE ADDITION OF A POST-FIXATION TISSUE HEAT TREATMENT STEP IN GLUTARALDEHYDE SOLUTION PRIOR TO THE EDWARDS XENOLOGIX TISSUE VALVE PROCESSING STEPS. THE DEVICES, AS MODIFIED, WILL BE MARKETED WITH THE REFERENCE TO THERMAFIX AS THE TRADEMARK/BRAND NAME FOR THE TISSUE PROCESSING METHOD AND WILL BE IDENTIFIED ACCORDING TO THE FOLLOWING MODIFIED MODEL NUMBERS: MODELS 2700TFX, 2800TFX, 6900PTFX, AND 3000TFX.

    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