PAI · Mesh, Surgical, Non-Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed
Obstetrics/Gynecology · 21 CFR 884.5980 · Class 3
Overview
| Product Code | PAI |
|---|---|
| Device Name | Mesh, Surgical, Non-Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed |
| Regulation | 21 CFR 884.5980 |
| Device Class | Class 3 |
| Review Panel | Obstetrics/Gynecology |
| Implant | Yes |
Identification
Surgical mesh for transvaginal pelvic organ prolapse repair is a prescription device intended to reinforce soft tissue in the pelvic floor. This device is a porous implant that is made of synthetic material, non-synthetic material, or a combination of synthetic and non-synthetic materials. This device does not include surgical mesh for other intended uses (§ 878.3300 of this chapter).
Classification Rationale
Class III (premarket approval).
Recent Cleared Devices (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K130006 | BIODESIGN SURGISIS ANTERIOR POSTERIOR PELVIC FLOOR GRAFTS | Cook Biotech Incorporated | Apr 5, 2013 | SESE |
| K050355 | PERMACOL SURGICAL IMPLANT T-PIECE, PERMACOL SURGICAL IMPLANT RECTOCELE-PIECE, MODELS 5928-150, 5645-150 | Tissue Science Laboratories, Plc | Mar 9, 2005 | SESE |
Top Applicants
- Cook Biotech Incorporated — 1 clearance
- Tissue Science Laboratories, Plc — 1 clearance
