BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Transcatheter Septal Occluder

    PMA: P040040 · Supplement: S045 · Decision Jan 13, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11

    Basic Information

    Device Name
    Transcatheter Septal Occluder
    Trade Name
    Amplatzer Muscular VSD Occluder
    PMA Number
    P040040
    Supplement Number
    S045
    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
    January 13, 2022
    Date Received
    November 22, 2021
    Supplement Type
    Real-Time Process
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    Approval for labeling changes to update the MRI Conditional information in the Instructions for Use (IFU) and Patient Implant Cards (PIC) supplied with the impacted Amplatzer Occluder devices.

    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