FDA product code PAG: Mesh, Surgical, Non-Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
PAG is the FDA product code for mesh, surgical, non-synthetic, urogynecologic, for stress urinary incontinence, retropubic or transobturator. It is a Class II device, regulated under 21 CFR 878.3300 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 9 510(k) submissions under PAG, from 5 different applicants. The average 510(k) review took 57 days (median 40).
Definition
Transvaginal surgical repair of female stress urinary incontinence (SUI) due to intrinsic sphincter deficiency (ISD) and/or urethral hypermobility.
Classification
| Field | Value |
|---|---|
| Device name | Mesh, Surgical, Non-Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator |
| Device class | Class II |
| Regulation | 21 CFR 878.3300 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) |
| Implant | Yes |
Compare with all 510(k) review times · Search every PAG clearance
Top PAG applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Cook Biotech, Inc. | 3 | 2009-07-10 |
| C.R. Bard, Inc. | 2 | 2004-11-09 |
| Brennen Medical, Inc. | 2 | 2003-03-07 |
| American Medical Systems, Inc. | 1 | 2005-06-17 |
| Advanced Uroscience, Inc. | 1 | 1999-11-05 |
Most recent PAG clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K090688 | Cook Biotech, Inc. | COOK UROLOGICAL GRAFT | 2009-07-10 | 116 |
| K050445 | American Medical Systems, Inc. | AMS COLLAGEN DERMAL MATRIX | 2005-06-17 | 115 |
| K042949 | C.R. Bard, Inc. | PELVILACE TRANSOBTURATOR BIOURETHRAL SUPPORT SYSTEM (PELVILACE TO SYSTEM) | 2004-11-09 | 14 |
| K031295 | C.R. Bard, Inc. | BARD INNERLACE BIOURETHRAL SUPPORT SYSTEM | 2003-05-15 | 22 |
| K030460 | Brennen Medical, Inc. | MODIFICATION TO BRENNEN BIOSYNTHETIC SURGICAL MESH MATRIX | 2003-03-07 | 23 |
Recalls for PAG devices
openFDA lists no recalls for product code PAG.
Frequently asked questions
What is FDA product code PAG?
PAG is the FDA product code for mesh, surgical, non-synthetic, urogynecologic, for stress urinary incontinence, retropubic or transobturator. It is a Class II device, regulated under 21 CFR 878.3300 and reviewed by the Gastroenterology and Urology panel.
What device class is PAG?
Class II, regulation 21 CFR 878.3300. Typical premarket route: 510(k).
How long does a 510(k) take for product code PAG?
Across 9 cleared submissions the average was 57 days from receipt to decision (median 40).
Which companies have the most PAG clearances?
Cook Biotech, Inc. (3); C.R. Bard, Inc. (2); Brennen Medical, Inc. (2); American Medical Systems, Inc. (1); Advanced Uroscience, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code PAG
- Run a recall and safety report across every PAG manufacturer
- Watch product code PAG 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 Gastroenterology and Urology product codes · FDA product code lookup · 510(k) database search · 510(k) review times