# Prosthesis, Breast, Inflatable, Internal, Saline
> **Product code: FWM** · Class III — High Risk (PMA approval required, life-sustaining) · General, Plastic Surgery · 21 CFR 878.3530
## Classification
- **FDA Product Code:** FWM
- **Device class:** Class III — High Risk (PMA approval required, life-sustaining)
- **Regulation:** 21 CFR 878.3530
- **Review panel:** SU
- **Medical specialty:** General, Plastic Surgery
- **Submission type:** 2
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** Y
- **Third-party review:** N
## Definition

Call for PMAs to be filed by 11/17/99 per 64 FR 45161 on 8/19/99

## Market data
- **Cleared 510(k) submissions:** 0
- **Registered establishments:** 8
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=FWM)
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