PAI
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Mesh, Surgical, Non-Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed
- Device class
- Class III (high risk)
- Regulation
- 21 CFR 884.5980
- Medical specialty
- Obstetrics/Gynecology
- Flags
- Implant
- FDA definition
- Tissue reinforcement of the fibromuscular layer of the pelvic floor when surgical treatment is indicated; procedures include anterior and posterior vaginal wall prolapse repair and vaginal apical and uterine prolapse repair completed transvaginally.
- Adverse events (MAUDE)
- 2013: 29 · 2014: 9 · 2015: 10 · 2016: 106
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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| Record | Firm | Date | Builder |
|---|---|---|---|
| BIODESIGN SURGISIS ANTERIOR POSTERIOR PELVIC FLOOR GRAFTS (K130006) | Cook Biotech Incorporated | 2013-04-05 | + Add |
| PERMACOL SURGICAL IMPLANT T-PIECE, PERMACOL SURGICAL IMPLANT RECTOCELE-PIECE, MODELS 5928-150, 5645-150 (K050355) | Tissue Science Laboratories, Plc | 2005-03-09 | + Add |
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