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U.S. Department of Health and Human Services

Product Classification

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Device mesh, surgical, for stress urinary incontinence, male
Regulation Description Surgical mesh.
Definition Surgical treatment of male stress urinary incontinence post-prostatectomy.
Physical State biologic (e.g., collagen) and/or synthetic (e.g, metallic or polymeric) woven fabric of varying design and material properties
Technical Method permanently implantable sling placed under the urethra; during instances of increased abdominal pressure (e.g., coughing, laughing, sneezing, etc.), device applies pressure to the urethra to prevent urine leakage
Target Area bladder, urethra
Regulation Medical Specialty General & Plastic Surgery
Review Panel Gastroenterology/Urology
Product CodeOTM
Premarket Review Office of Device Evaluation (ODE)
Division of Reproductive, Gastro-Renal, and Urological Devices (DRGUD)
Urology and Lithotripsy Devices Branch (ULDB)
Submission Type 510(k)
Regulation Number 878.3300
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Implanted Device? Yes
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible