Browse hierarchy: [Cardiovascular (CV)](/submissions/CV) → [Subpart D — Cardiovascular Prosthetic Devices](/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices) → [21 CFR 870.3470](/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/870.3470) → OMH — Pericardial Patch To Facilitate Revision Surgeries

# OMH · Pericardial Patch To Facilitate Revision Surgeries

_Cardiovascular · 21 CFR 870.3470 · Class 2_

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

## Overview

- **Product Code:** OMH
- **Device Name:** Pericardial Patch To Facilitate Revision Surgeries
- **Regulation:** [21 CFR 870.3470](/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/870.3470)
- **Device Class:** 2
- **Review Panel:** [Cardiovascular](/submissions/CV)
- **Implant:** yes
- **Life-sustaining:** yes

## Identification

An intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene is a fabric device placed in the heart that is used to repair septal defects, for patch grafting, to repair tissue, and to buttress sutures.

## Classification Rationale

Class II (performance standards).

## Recent Cleared Devices (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K031785](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/OMH/K031785.md) | MACROPORE CARDIO-WRAP (TS) | Macropore Biosurgery, Inc. | Sep 4, 2003 | SESE |

## Top Applicants

- Macropore Biosurgery, Inc. — 1 clearance

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

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