Product code PAG— General, Plastic Surgery
MODIFICATION TO BRENNEN BIOSYNTHETIC SURGICAL MESH MATRIX
- Classification name
- Mesh, Surgical, Non-Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
- Device class
- Class 2
- Regulation
- 21 CFR 878.3300
- Advisory panel
- General, Plastic Surgery
- Total cleared
- 9
- First cleared
- Most recent
FDA classification definition
“Transvaginal surgical repair of female stress urinary incontinence (SUI) due to intrinsic sphincter deficiency (ISD) and/or urethral hypermobility.”
Market context for product code PAG
FDA has cleared devices under product code PAG between 1998 and 2009, filed by 5 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2009
- 2005
- 2004
- 2003
- 2002
- 1999
- 1998
Top applicants under product code PAG
Recent clearances under product code PAG
- K090688 — COOK UROLOGICAL GRAFT
- K050445 — AMS COLLAGEN DERMAL MATRIX
- K042949 — PELVILACE TRANSOBTURATOR BIOURETHRAL SUPPORT SYSTEM (PELVILACE TO SYSTEM)
- K031295 — BARD INNERLACE BIOURETHRAL SUPPORT SYSTEM
- K030460 — MODIFICATION TO BRENNEN BIOSYNTHETIC SURGICAL MESH MATRIX
- K020654 — STRATASIS SLING KIT
- K993459 — MODIFICATION TO BRENNEN BIOSYNTHETIC SURGICAL MESH MATRIX
- K992159 — SURGISIS SLING
- K982403 — BRENNEN BIOSYNTHETIC SURGICAL MESH MATRIX
Data sourced from openFDA. This site is unofficial and independent of the FDA.