BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Transcatheter Septal Occluder

    PMA: P000049 · Supplement: S012 · Decision May 10, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11

    Basic Information

    Device Name
    Transcatheter Septal Occluder
    Trade Name
    CARDIOSEAL SEPTAL OCCLUSION SYSTEM WITH QWIKLOAD
    PMA Number
    P000049
    Supplement Number
    S012
    Device Class
    FDA Class 3
    Product Code
    MLV
    Generic Name
    Transcatheter septal occluder
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    May 10, 2004
    Date Received
    April 2, 2004
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE ADDITION OF A WARNING TO THE LABELING THAT PROTAMINE SULFATE SHOULD NOT BE USED FOR HEPARIN REVERSAL BECAUSE OF THE POTENTIAL FOR THROMBUS FORMATION.

    Classifications

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

    Product Code Device Name
    MLV Transcatheter Septal Occluder