PAG — Mesh, Surgical, Non-Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator Class II
Classification Details
- Product Code
- PAG
- Device Class
- Class II
- Regulation Number
- 878.3300
- Submission Type
- Review Panel
- GU
- Medical Specialty
- General, Plastic Surgery
- Implant
- Yes
Definition
Transvaginal surgical repair of female stress urinary incontinence (SUI) due to intrinsic sphincter deficiency (ISD) and/or urethral hypermobility.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K090688 | cook biotech | COOK UROLOGICAL GRAFT | July 10, 2009 |
| K050445 | american medical systems | AMS COLLAGEN DERMAL MATRIX | June 17, 2005 |
| K042949 | c.r. bard | PELVILACE TRANSOBTURATOR BIOURETHRAL SUPPORT SYSTEM (PELVILACE TO SYSTEM) | November 9, 2004 |
| K031295 | c.r. bard | BARD INNERLACE BIOURETHRAL SUPPORT SYSTEM | May 15, 2003 |
| K030460 | brennen medical | MODIFICATION TO BRENNEN BIOSYNTHETIC SURGICAL MESH MATRIX | March 7, 2003 |
| K020654 | cook biotech | STRATASIS SLING KIT | April 9, 2002 |
| K993459 | advanced uroscience | MODIFICATION TO BRENNEN BIOSYNTHETIC SURGICAL MESH MATRIX | November 5, 1999 |
| K992159 | cook biotech | SURGISIS SLING | September 23, 1999 |
| K982403 | brennen medical | BRENNEN BIOSYNTHETIC SURGICAL MESH MATRIX | September 22, 1998 |