# PAH: Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-Sling

- Device class: 2; regulation: 21 CFR 878.3300; FDA's rule: 510(k) required
- FDA decisions: 20
- 510(k) review time 2021–2025: median 146 days (middle half 102–189)
- Recalls: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2006: 1
- 2007: 2
- 2008: 3
- 2009: 2
- 2010: 1
- 2011: 1
- 2012: 4
- 2020: 1
- 2023: 1
- 2024: 1

## Most-cited predicates
- K073703: Ams Miniarc Sling System (2008), cited by 5
- K052401: Gynecare TVT Secur System (2005), cited by 3
- K081275: Boston Scientific Surgical Mesh (2008), cited by 3
- K070065: Ams Single Incision Sling System (Sis-0) (2007), cited by 2
- K100807: Miniarc Precise Single-Incision Sling System Model: 720181, 720191 (2010), cited by 2
- K092607: Ajust Adjustable Single Incision Sling (2009), cited by 2
- K020652: Herniamesh T-Sling (2002), cited by 2
- K023898: Gyne Ideas Minitape RP Device (2003), cited by 2
- K071902: Ams Miniarc Sling System (2007), cited by 2
- K191416: Desara One Single Incision Sling System, 1 Pack ; Desara One Single Incision Sling System, 3 Pack (2020), cited by 1

Source page: https://510kreport.com/product-code/PAH
Data by year (CSV): https://510kreport.com/product-code/PAH.csv