BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Barrier, Absorbable, Adhesion

    PMA: P050011 · Decision Jul 28, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    17
    Registration Numbers
    17

    Basic Information

    Device Name
    Barrier, Absorbable, Adhesion
    Trade Name
    ADEPT (4% ICODEXTRIN) ADHESION REDUCTION SOLUTION
    PMA Number
    P050011
    Device Class
    FDA Class 3
    Product Code
    MCN
    Generic Name
    Barrier, absorbable, adhesion
    Medical Specialty
    Unknown
    Advisory Committee
    Obstetrics/Gynecology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    July 28, 2006
    Date Received
    March 16, 2005
    Expedited Review
    N
    Docket Number
    06M-0322

    Advisory Committee Statement

    APPROVAL FOR THE ADEPT (4% ICODEXTRIN) ADHESION REDUCTION SOLUTION. THE DEVICE IS INDICATED FOR USE INTRAPERIOTONEALLY AS AN ADJUNCT TO GOOD SURGICAL TECHNIQUE FOR THE REDUCTION OF POST-SURGICAL ADHESIONS IN PATIENTS UNDERGOING GYNECOLOGICAL LAPAROSCOPIC ADHESIOLYSIS.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MCN Barrier, Absorbable, Adhesion