BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    PFR SLING SYSTEM, PART OF THE AMS PELVIC FLOOR REPAIR SYSTEM

    K Number: K090934 · Decision Jun 2, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    140
    Registration Numbers
    140
    Same Product Code
    332
    Applicant Total
    72
    Review Days
    61

    Basic Information

    Device Name
    PFR SLING SYSTEM, PART OF THE AMS PELVIC FLOOR REPAIR SYSTEM
    K Number
    K090934
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    878.3300
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    AMERICAN MEDICAL SYSTEMS, INC.
    Date Received
    April 2, 2009
    Decision Date
    June 2, 2009
    Product Code
    FTL
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    FTL Mesh, Surgical, Polymeric

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