BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    System, Appendage Closure, Left Atrial

    PMA: P130013 · Decision Mar 13, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13

    Basic Information

    Device Name
    System, Appendage Closure, Left Atrial
    Trade Name
    WATCHMAN LEFT ATRIAL APPENDAGE (LAA) CLOSURE TECHNOLOGY
    PMA Number
    P130013
    Device Class
    FDA Class 3
    Product Code
    NGV
    Generic Name
    System, appendage closure, left atrial
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    March 13, 2015
    Date Received
    May 14, 2013
    Expedited Review
    Y
    Docket Number
    15M-0910

    Advisory Committee Statement

    APPROVAL FOR THE WATCHMAN LAA CLOSURE TECHNOLOGY. THIS DEVICE IS INDICATED TO REDUCE THE RISK OF THROMBOEMBOLISM FROM THE LEFT ATRIAL APPENDAGE (LAA) IN PATIENTS WITH NON-VALVULAR ATRIAL FIBRILLATION WHO: ARE AT INCREASED RISK FOR STROKE AND SYSTEMIC EMBOLISM BASED ON CHADS2 OR CHA2DS2-VASC SCORES AND ARE RECOMMENDED FOR ANTICOAGULATION THERAPY; ARE DEEMED BY THEIR PHYSICIANS TO BE SUITABLE FOR WARFARIN; AND HAVE AN APPROPRIATE RATIONALE TO SEEK A NON-PHARMACOLOGIC ALTERNATIVE TO WARFARIN, TAKING INTO ACCOUNT THE SAFETY AND EFFECTIVENESS OF THE DEVICE COMPARED TO WARFARIN.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    NGV System, Appendage Closure, Left Atrial