FDA product code FTR: Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled
FTR is the FDA product code for prosthesis, breast, noninflatable, internal, silicone gel-filled. It is a Class III device, regulated under 21 CFR 878.3540 and reviewed by the General and Plastic Surgery panel. Devices under FTR reach the market by PMA; FDA lists no cleared 510(k)s for it. 6 PMA applications cite this product code. FDA has posted 14 recalls for FTR devices.
Definition
Call for pmas to be filed by 7/9/91 per 56 fr 14627 on 4/10/91
Classification
| Field | Value |
|---|---|
| Device name | Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled |
| Device class | Class III |
| Regulation | 21 CFR 878.3540 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | PMA |
| Implant | Yes |
Recalls for FTR devices
14 product recalls in 4 recall events; 0 initiated in the last five years and 10 still open. Most recent: 2019-11-06.
| Year | Recalls |
|---|---|
| 2019 | 12 |
Frequently asked questions
What is FDA product code FTR?
FTR is the FDA product code for prosthesis, breast, noninflatable, internal, silicone gel-filled. It is a Class III device, regulated under 21 CFR 878.3540 and reviewed by the General and Plastic Surgery panel.
What device class is FTR?
Class III, regulation 21 CFR 878.3540. Typical premarket route: PMA.
Have FTR devices been recalled?
Yes: 14 product recalls across 4 recall events; the most recent began 2019-11-06.
Next steps
- Run an FDA pathway report with predicate devices for product code FTR
- Run a recall and safety report across every FTR manufacturer
- Watch product code FTR for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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