Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed
OTP is the FDA product code for Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed, a class III device type, regulated under 21 CFR 884.5980. FDA's definition for this code reads: "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 or uterine prolapse repair performed transvaginally". As of , FDA records hold 31 510(k) clearances under this code, the most recent dated , and no recalls.
Classification record
- Product code
- OTP
- Device name
- Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed
- FDA 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 or uterine prolapse repair performed transvaginally
- Regulation
- 21 CFR 884.5980
- Device class
- Class III
- Review panel
- Obstetrics/Gynecology
- Submission type
- PMA
- Implant
- Yes
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 31
- Ingested recalls
- 0
Clearances, product code OTP
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 2003 | 1 |
| 2004 | 3 |
| 2005 | 2 |
| 2007 | 4 |
| 2008 | 8 |
| 2009 | 6 |
| 2011 | 5 |
| 2012 | 2 |
Applicants with the most clearances
Product code OTP| Applicant | Clearances |
|---|---|
| American Medical Systems, Inc. | 13 |
| Boston Scientific Corporation | 5 |
| C.R. Bard Inc | 3 |
| MEDLINE INDUSTRIES, LP - Northfield | 2 |
| Ethicon, Inc | 2 |
| Sofradim Production | 2 |
| Caldera Medical, Inc. | 1 |
| Mentor | 1 |
| Mpathy Medical Devices, Ltd. | 1 |
| Neomedic International | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
