# Heart Valve, More Than Minimally Manipulated Allograft
> **Product code: OHA** · Unclassified · Unknown · —
## Classification
- **FDA Product Code:** OHA
- **Device class:** Unclassified
- **Regulation:** —
- **Review panel:** CV
- **Medical specialty:** Unknown
- **Submission type:** 1
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** Y
- **Third-party review:** N
## Definition

For the replacement of diseased, damaged, malformed or malfunctioning native or prosthetic pulmonary heart valves.  They may also be used in the replacement of native pulmonary heart valves when the ross procedure is performed.  Pulmonary heart valve allografts are used to repair both congential and acquired valvular lesions.

## Market data
- **Cleared 510(k) submissions:** 4
- **Registered establishments:** 2
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=OHA)
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