BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Transcatheter Septal Occluder

    PMA: P040040 · Decision Sep 7, 2007
    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
    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
    September 7, 2007
    Date Received
    September 30, 2004
    Expedited Review
    N
    Docket Number
    07M-0446

    Advisory Committee Statement

    APPROVAL FOR THE AMPLATZER MUSCULAR VSD OCCLUDER. THE DEVICE IS INDICATED FOR USE IN PATIENTS WITH A COMPLEX VENTRICULAR SEPTAL DEFECT (VSD) OF SIGNIFICANT SIZE TO WARRANT CLOSURE (LARGE VOLUME LEFT TO RIGHT SHUNT, PULMONARY HYPERTENSION AND/OR CLINICAL SYMPTOMS OF CONGESTIVE HEART FAILURE) WHO ARE CONSIDERED TO BE AT HIGH RISK FOR STANDARD TRANSATRIAL OR TRANSARTERIAL SURGICAL CLOSURE BASED ON ANATOMICAL CONDITIONS AND/OR BASED ON OVERALL MEDICAL CONDITION. HIGH RISK ANATOMICAL FACTORS FOR TRANSATRIAL OR TRANSARTERIAL SURGICAL CLOSURE INCLUDE PATIENTS: 1) REQUIRING LEFT VENTRICULOTOMY OR AN EXTENSIVE RIGHT VENTRICULOTOMY; 2) WITH A FAILED PREVIOUS VSD CLOSURE; 3) WITH MULTIPLE APICAL AND/OR ANTERIOR MUSCULAR VSDS (?SWISS CHEESE SEPTUM?); OR 4) WITH POSTERIOR APICAL VSDS COVERED BY TRABECULAE.

    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