BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Material, Dressing, Surgical, Polylactic Acid

    PMA: P840062 · Supplement: S033 · Decision Apr 7, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6

    Basic Information

    Device Name
    Material, Dressing, Surgical, Polylactic Acid
    Trade Name
    COLLAPLUG ABSORBABLE COLLAGEN WOUND DRESSING FOR DENTAL SURGERY
    PMA Number
    P840062
    Supplement Number
    S033
    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
    April 7, 2014
    Date Received
    August 5, 2013
    Supplement Type
    135 Review Track For 30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE FOLLOWING PROPOSED CHANGES: 1) A NEW ALKALINE DETERGENT FOR USE AS A CLEANING AGENT; 2) PROPOSED USE OF TOTAL ORGANIC CARBONS (TOCS) AS A METHOD TO TEST FOR RESIDUES; 3) SWAB AND RINSE RECOVERY FACTORS AND A VISUAL LIMIT OF DETECTION FOR MEDICAL MANUFACTURING AREA SOIL ON STAINLESS STEEL AND ALUMINUM SURFACES; 4) PROPOSED CHANGE IN EQUIPMENT DIRTY HOLD TIMES (DHTS) FOR THE DOUBLE DENSITY HEMOSTATIC DISPERSION, CROSS-LINKING PROCESS EQUIPMENT AND THE MOLD FILLING EQUIPMENT; AND5) PROPOSED INSTALLATION AND OPERATIONAL QUALIFICATION OF A NEW ULTRASONICATOR.

    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