# PAI: Mesh, Surgical, Non-Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed

- Device class: 3; regulation: 21 CFR 884.5980; FDA's rule: PMA required
- FDA decisions: 2
- Recalls: 0 (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)
- 2005: 1
- 2013: 1

## Most-cited predicates
- K050355: Permacol Surgical Implant T-Piece, Permacol Surgical Implant Rectocele-Piece, Models 5928-150, 5645-150 (2005), cited by 3

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