BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Transcatheter Septal Occluder

    PMA: P050006 · Supplement: S107 · Decision Mar 20, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11

    Basic Information

    Device Name
    Transcatheter Septal Occluder
    Trade Name
    GORE® CARDIOFORM ASD Occluder
    PMA Number
    P050006
    Supplement Number
    S107
    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 20, 2024
    Date Received
    September 22, 2023
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Labeling Change - PAS
    Expedited Review
    N

    Advisory Committee Statement

    modifications to the Instructions for Use to reflect the findings of the final Post-Approval Study (PAS) Report submitted for the Continued F/u of the ASSURED Study

    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