FDA product code PAI: Mesh, Surgical, Non-Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed
PAI is the FDA product code for mesh, surgical, non-synthetic, urogynecologic, for pelvic organ prolapse, transvaginally placed. It is a Class III device, regulated under 21 CFR 884.5980 and reviewed by the Obstetrics and Gynecology panel. FDA has cleared 2 510(k) submissions under PAI, from 2 different applicants. The average 510(k) review took 58 days (median 58).
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.
Classification
| Field | Value |
|---|---|
| Device name | Mesh, Surgical, Non-Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed |
| Device class | Class III |
| Regulation | 21 CFR 884.5980 |
| Review panel | OB — Obstetrics and Gynecology |
| Medical specialty | Obstetrics/Gynecology |
| Premarket route | PMA |
| Implant | Yes |
Compare with all 510(k) review times · Search every PAI clearance
Top PAI applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Cook Biotech Incorporated | 1 | 2013-04-05 |
| Tissue Science Laboratories, Plc | 1 | 2005-03-09 |
Most recent PAI clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K130006 | Cook Biotech Incorporated | BIODESIGN SURGISIS ANTERIOR POSTERIOR PELVIC FLOOR GRAFTS | 2013-04-05 | 93 |
| K050355 | Tissue Science Laboratories, Plc | PERMACOL SURGICAL IMPLANT T-PIECE, PERMACOL SURGICAL IMPLANT RECTOCELE-PIECE, MODELS 5928-150, 5645-150 | 2005-03-09 | 23 |
Recalls for PAI devices
openFDA lists no recalls for product code PAI.
Frequently asked questions
What is FDA product code PAI?
PAI is the FDA product code for mesh, surgical, non-synthetic, urogynecologic, for pelvic organ prolapse, transvaginally placed. It is a Class III device, regulated under 21 CFR 884.5980 and reviewed by the Obstetrics and Gynecology panel.
What device class is PAI?
Class III, regulation 21 CFR 884.5980. Typical premarket route: PMA.
How long does a 510(k) take for product code PAI?
Across 2 cleared submissions the average was 58 days from receipt to decision (median 58).
Which companies have the most PAI clearances?
Cook Biotech Incorporated (1); Tissue Science Laboratories, Plc (1).
Next steps
- Run an FDA pathway report with predicate devices for product code PAI
- Run a recall and safety report across every PAI manufacturer
- Watch product code PAI for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
All Obstetrics and Gynecology product codes · FDA product code lookup · 510(k) database search · 510(k) review times