# Pericardial Patch To Facilitate Revision Surgeries
> **Product code: OMH** · Class II — Moderate Risk (510(k) clearance required) · Cardiovascular · 21 CFR 870.3470
## Classification
- **FDA Product Code:** OMH
- **Device class:** Class II — Moderate Risk (510(k) clearance required)
- **Regulation:** 21 CFR 870.3470
- **Review panel:** CV
- **Medical specialty:** Cardiovascular
- **Submission type:** 1
- **GMP exempt:** N
- **Life sustaining:** Y
- **Implant:** Y
- **Third-party review:** N
## Definition

Pericardial patch or pledget with the secondary function of facilitating revision surgeries by providing a plane of dissection.  Does not include devices whose primary purpose is to minimize the incidence or severity of adhesion formation as a result of cardiac surgery.

## Market data
- **Cleared 510(k) submissions:** 1
- **Registered establishments:** 3
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=OMH)
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