Browse hierarchy: [General, Plastic Surgery (SU)](/submissions/SU) → [Subpart D — Prosthetic Devices](/submissions/SU/subpart-d%E2%80%94prosthetic-devices) → [21 CFR 878.3300](/submissions/SU/subpart-d%E2%80%94prosthetic-devices/878.3300) → PAJ — Mesh, Surgical, Non-Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed

# PAJ · Mesh, Surgical, Non-Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed

_General, Plastic Surgery · 21 CFR 878.3300 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/PAJ

## Overview

- **Product Code:** PAJ
- **Device Name:** Mesh, Surgical, Non-Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed
- **Regulation:** [21 CFR 878.3300](/submissions/SU/subpart-d%E2%80%94prosthetic-devices/878.3300)
- **Device Class:** 2
- **Review Panel:** [General, Plastic Surgery](/submissions/SU)
- **Implant:** yes

## Identification

Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.

## Classification Rationale

Class II.

## Recent Cleared Devices (2 of 2)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K051190](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/PAJ/K051190.md) | XENFORM SOFT TISSUE REPAIR MATRIX | Tei Biosciences, Inc. | Jun 10, 2005 | SESE |
| [K002233](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/PAJ/K002233.md) | BVI SLING | Bio-Vascular, Inc. | Oct 13, 2000 | SESE |

## Top Applicants

- Tei Biosciences, Inc. — 1 clearance
- Bio-Vascular, Inc. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/PAJ](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/PAJ)

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