BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Replacement Heart-Valve

    PMA: P860057 · Supplement: S196 · Decision Apr 10, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11

    Basic Information

    Device Name
    Replacement Heart-Valve
    Trade Name
    Carpentier-Edwards PERIMOUNT, Plus, Theon, RSR, Magna,Magna Ease, Mega Mitral Pericardial Aortic Bioprosthesis with Ther
    PMA Number
    P860057
    Supplement Number
    S196
    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
    April 10, 2020
    Date Received
    November 18, 2019
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Location Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Approval for a manufacturing site located at Edwards Lifesciences (Singapore) Pte. Ltd, 35 Changi North Crescent, Singapore 499641 SG, to receive and process bovine pericardial tissue sacs into treated tissue heart valve leaflets.

    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