# Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled
> **Product code: FTR** · Class III — High Risk (PMA approval required, life-sustaining) · General, Plastic Surgery · 21 CFR 878.3540
## Classification
- **FDA Product Code:** FTR
- **Device class:** Class III — High Risk (PMA approval required, life-sustaining)
- **Regulation:** 21 CFR 878.3540
- **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 7/9/91 per 56 fr 14627 on 4/10/91

## 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=FTR)
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