FDA product code PAJ: Mesh, Surgical, Non-Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed
PAJ is the FDA product code for mesh, surgical, non-synthetic, urogynecologic, for apical vaginal and uterine prolapse, transabdominally placed. It is a Class II device, regulated under 21 CFR 878.3300 and reviewed by the Obstetrics and Gynecology panel. FDA has cleared 2 510(k) submissions under PAJ, from 2 different applicants. The average 510(k) review took 56 days (median 56).
Definition
Bridging material to attach the vaginal apex or uterus to the sacral promontory; procedures include abdominal sacrocolpopexy, laparoscopic sacrocolpopexy and robot-assisted sacrocolpopexy.
Classification
| Field | Value |
|---|---|
| Device name | Mesh, Surgical, Non-Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed |
| Device class | Class II |
| Regulation | 21 CFR 878.3300 |
| Review panel | OB — Obstetrics and Gynecology |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) |
| Implant | Yes |
Compare with all 510(k) review times · Search every PAJ clearance
Top PAJ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Tei Biosciences, Inc. | 1 | 2005-06-10 |
| Bio-Vascular, Inc. | 1 | 2000-10-13 |
Most recent PAJ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K051190 | Tei Biosciences, Inc. | XENFORM SOFT TISSUE REPAIR MATRIX | 2005-06-10 | 31 |
| K002233 | Bio-Vascular, Inc. | BVI SLING | 2000-10-13 | 81 |
Recalls for PAJ devices
openFDA lists no recalls for product code PAJ.
Frequently asked questions
What is FDA product code PAJ?
PAJ is the FDA product code for mesh, surgical, non-synthetic, urogynecologic, for apical vaginal and uterine prolapse, transabdominally placed. It is a Class II device, regulated under 21 CFR 878.3300 and reviewed by the Obstetrics and Gynecology panel.
What device class is PAJ?
Class II, regulation 21 CFR 878.3300. Typical premarket route: 510(k).
How long does a 510(k) take for product code PAJ?
Across 2 cleared submissions the average was 56 days from receipt to decision (median 56).
Which companies have the most PAJ clearances?
Tei Biosciences, Inc. (1); Bio-Vascular, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code PAJ
- Run a recall and safety report across every PAJ manufacturer
- Watch product code PAJ 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.
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