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

    Transcatheter Septal Occluder

    PMA: P000049 · Supplement: S011 · Decision Mar 24, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11

    Basic Information

    Device Name
    Transcatheter Septal Occluder
    Trade Name
    CARDIOSEAL SEPTAL OCCULUSION SYSTEM WITH QWIK LOAD
    PMA Number
    P000049
    Supplement Number
    S011
    Device Class
    FDA Class 3
    Product Code
    MLV
    Generic Name
    Transcatheter septal occluder
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    March 24, 2004
    Date Received
    March 2, 2004
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    CHANGE IN THE MANUFACTURING PROCESS OF THE CARDIOSEAL SEPTAL OCCLUSION SYSTEM WITH QWIK LOAD WHICH INVOLVES A CHANGE TO THE BIOBURDEN SAMPLING PLAN TO ELIMINATE REDUNDANT QUARTERLY TESTING.

    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