BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Material, Dressing, Surgical, Polylactic Acid

    PMA: P800012 · Supplement: S009 · Decision Sep 17, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6

    Basic Information

    Device Name
    Material, Dressing, Surgical, Polylactic Acid
    Trade Name
    DRILAC CUBES AND GRANULES
    PMA Number
    P800012
    Supplement Number
    S009
    Device Class
    FDA Class 3
    Product Code
    LPG
    Generic Name
    MATERIAL, DRESSING, SURGICAL, POLYLACTIC ACID
    Medical Specialty
    Unknown
    Advisory Committee
    Dental
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    September 17, 2002
    Date Received
    August 12, 2002
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Express GMP Supplement
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR NEW MANUFACTURING AND STERILIZATION SITES. THE MANUFACTURING SITE IS LOCATED AT KENSEY NASH CORPORATION, EXTON, PA. THE NEW STERILIZATION SITE IS LOCATED AT STERIS ISOMEDIX SERVICES, WHIPPANY, NJ.

    Classifications

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

    Product Code Device Name
    LPG Material, Dressing, Surgical, Polylactic Acid