BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Transcatheter Septal Occluder

    PMA: P040040 · Supplement: S022 · Decision Oct 29, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11

    Basic Information

    Device Name
    Transcatheter Septal Occluder
    Trade Name
    AMPLATZER VSD MUSCULAR OCCLUDER
    PMA Number
    P040040
    Supplement Number
    S022
    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
    October 29, 2014
    Date Received
    February 6, 2013
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR CONVERTING THE NITINOL WIRE USED IN THE MANUFACTURE OF THESE DEVICES FROM A BLACK OXIDE SURFACE FINISH TO A CHEMICALLY ETCHED SURFACE FINISH.

    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