Browse hierarchy: [Obstetrics/Gynecology (OB)](/submissions/OB) → [Subpart F — Obstetrical and Gynecological Therapeutic Devices](/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices) → [21 CFR 884.5980](/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/884.5980) → PAI — Mesh, Surgical, Non-Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed

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

_Obstetrics/Gynecology · 21 CFR 884.5980 · Class 3_

**Canonical URL:** https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/PAI

## Overview

- **Product Code:** PAI
- **Device Name:** Mesh, Surgical, Non-Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed
- **Regulation:** [21 CFR 884.5980](/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/884.5980)
- **Device Class:** 3
- **Review Panel:** [Obstetrics/Gynecology](/submissions/OB)
- **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](https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/PAI/K130006.md) | BIODESIGN SURGISIS ANTERIOR POSTERIOR PELVIC FLOOR GRAFTS | Cook Biotech Incorporated | Apr 5, 2013 | SESE |
| [K050355](https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/PAI/K050355.md) | 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

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**Source:** [https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/PAI](https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/PAI)

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