PAG
9 FDA 510(k) clearances · Product code
40 daysmedian time to decision
116 days90th percentile
9clearances measured
FDA profile
- Official device name
- Mesh, Surgical, Non-Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.3300
- Medical specialty
- General, Plastic Surgery
- Flags
- Implant
- FDA definition
- Transvaginal surgical repair of female stress urinary incontinence (SUI) due to intrinsic sphincter deficiency (ISD) and/or urethral hypermobility.
- Adverse events (MAUDE)
- 2013: 84 · 2014: 256 · 2015: 73 · 2016: 299 · 2017: 11 · 2019: 17
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| COOK UROLOGICAL GRAFT (K090688) | Cook Biotech, Inc. | 2009-07-10 |
| AMS COLLAGEN DERMAL MATRIX (K050445) | American Medical Systems, Inc. | 2005-06-17 |
| PELVILACE TRANSOBTURATOR BIOURETHRAL SUPPORT SYSTEM (PELVILACE TO SYSTEM) (K042949) | C.R. Bard, Inc. | 2004-11-09 |
| BARD INNERLACE BIOURETHRAL SUPPORT SYSTEM (K031295) | C.R. Bard, Inc. | 2003-05-15 |
| MODIFICATION TO BRENNEN BIOSYNTHETIC SURGICAL MESH MATRIX (K030460) | Brennen Medical, Inc. | 2003-03-07 |
| STRATASIS SLING KIT (K020654) | Cook Biotech, Inc. | 2002-04-09 |
| MODIFICATION TO BRENNEN BIOSYNTHETIC SURGICAL MESH MATRIX (K993459) | Advanced Uroscience, Inc. | 1999-11-05 |
| SURGISIS SLING (K992159) | Cook Biotech, Inc. | 1999-09-23 |
| BRENNEN BIOSYNTHETIC SURGICAL MESH MATRIX (K982403) | Brennen Medical, Inc. | 1998-09-22 |
Track PAG automatically
Every clearance here is in the API, with alerts when new ones post.