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 Code | OTM |
Premarket Review |
Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices
(OHT3)
Reproductive, Gynecology and Urology Devices
(DHT3B)
|
Submission Type |
510(k)
|
Regulation Number |
878.3300
|
Device Class |
2
|
Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
GMP Exempt? |
No
|
Summary Malfunction Reporting |
Ineligible |
Implanted Device? |
Yes
|
Life-Sustain/Support Device? |
No
|
Third Party Review |
Not Third Party Eligible |
|
|