PAIClass III
Mesh, Surgical, Non-Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed
21 CFR 884.5980 / Obstetrics/Gynecology
PAI is the FDA product code for Mesh, Surgical, Non-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 and uterine prolapse repair completed transvaginally". As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.
Classification record
- Product code
- PAI
- Device name
- Mesh, Surgical, Non-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 and uterine prolapse repair completed 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
- 2
- Ingested recalls
- 0
Clearances, product code PAI
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 2005 | 1 |
| 2013 | 1 |
Applicants with the most clearances
Product code PAI| Applicant | Clearances |
|---|---|
| Cook Biotech Incorporated | 1 |
| Tissue Science Laboratories, PLC | 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.