BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Barrier, Absorbable, Adhesion

    PMA: P050011 · Supplement: S008 · Decision Aug 21, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    17
    Registration Numbers
    17

    Basic Information

    Device Name
    Barrier, Absorbable, Adhesion
    Trade Name
    ADEPT Adhesion Reduction Solution
    PMA Number
    P050011
    Supplement Number
    S008
    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
    August 21, 2020
    Date Received
    April 13, 2020
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for bag fill volume changes to the polyvinylchloride storage bag for the ADEPT® Adhesion Reduction Solution.

    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