BEUDAMED
    Product Code: PAI FDA class 3 21 CFR 884.5980

    Mesh, Surgical, Non-Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed

    Obstetrics/Gynecology

    The Mesh, Surgical, Non-Synthetic, Urogynecologic, for Pelvic Organ Prolapse, Transvaginally Placed is a non-synthetic surgical mesh implant used for tissue reinforcement of the fibromuscular layer of the pelvic floor in transvaginal repair procedures for anterior and posterior vaginal wall prolapse, vaginal apical prolapse, and uterine prolapse. It is classified as Class 3 (FDA Class 3), requiring Premarket Approval (PMA) under regulation number 884.5980, reflecting the elevated risk of transvaginally placed pelvic mesh. The product code is PAI under the Obstetrics/Gynecology specialty, and it carries an implant flag.

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    510(k)s
    2
    FEI Numbers
    2
    Registration Numbers
    2
    Unique Applicants
    2
    Years Active
    8

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    Basic Information

    Product Code
    PAI
    Device Class
    FDA class 3
    Regulation Number
    884.5980
    Medical Specialty
    Obstetrics/Gynecology
    Review Panel
    OB
    Submission Type
    2

    Device Characteristics

    ✗
    GMP Exempt
    ✓
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    Definition

    Tissue reinforcement of the fibromuscular layer of the pelvic floor when surgical treatment is indicated; procedures include anterior and posterior vaginal wall prolapse repair and vaginal apical and uterine prolapse repair completed transvaginally.

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 2 510(k) clearances via K numbers.

    K Number Device Name
    K130006 BIODESIGN SURGISIS ANTERIOR POSTERIOR PELVIC FLOOR GRAFTS
    K050355 PERMACOL SURGICAL IMPLANT T-PIECE, PERMACOL SURGICAL IMPLANT RECTOCELE-PIECE, MODELS 5928-150, 5645-150

    FEI Numbers

    This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.