BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Barrier, Absorbable, Adhesion

    PMA: P950034 · Supplement: S017 · Decision Dec 20, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    17
    Registration Numbers
    17

    Basic Information

    Device Name
    Barrier, Absorbable, Adhesion
    Trade Name
    SEPRAFILM(R) BIORESORBABLE MEMBRAND
    PMA Number
    P950034
    Supplement Number
    S017
    Device Class
    FDA Class 3
    Product Code
    MCN
    Generic Name
    Barrier, absorbable, adhesion
    Medical Specialty
    Unknown
    Advisory Committee
    General, Plastic Surgery
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    December 20, 2000
    Date Received
    November 28, 2000
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A NEW SIZE OF SEPRAFILM(R) AND TO CHANGE THE NAME OF THE PRODUCT FROM SEPRAFILM(R) BIORESORBABLE MEMBRANE TO SEPRAFILM(R) ADHESION BARRIER. THE LABELING HAS BEEN MODIFIED TO REFLECT THE NEW NAME AND NEW SIZE AND THE PACKAGE INSERT WAS MODIFIED TO BE INCLUDED WITH BOTH SIZES. FURTHERMORE, THE LABELING HAS BEEN MODIFIED TO OMIT THE REFERENCE TO THE CLINICAL STUDY IN THE FOREIGN BODY PRECAUTION.

    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