BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Transcatheter Septal Occluder

    PMA: P050006 · Supplement: S060 · Decision Mar 30, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11

    Basic Information

    Device Name
    Transcatheter Septal Occluder
    Trade Name
    GORE CARDIOFORM Septal Occluder
    PMA Number
    P050006
    Supplement Number
    S060
    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
    March 30, 2018
    Date Received
    July 31, 2017
    Supplement Type
    Panel Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N
    Docket Number
    18M-1372

    Advisory Committee Statement

    Approval for the GORE CARDIOFORM Septal Occluder. The GORE CARDIOFORM Septal Occluder is a permanently implanted device indicated for the percutaneous, transcatheter closure of the following defects of the atrial septum:1) ostium secundum atrial septal defects (ASDs); and2) patent foramen ovale (PFO) to reduce the risk of recurrent ischemic stroke in patients, predominantly between the ages of 18 and 60 years, who have had a cryptogenic stroke due to a presumed paradoxical embolism, as determined by a neurologist and cardiologist following an evaluation to exclude known causes of ischemic stroke.

    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