FDA device listing
Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled
FDA device listing 1369526295 · PRO-TECH Design & Mfg, Inc.
Key facts
| Owner/operator | PRO-TECH Design & Mfg, Inc. |
|---|---|
| Owner/operator number | 9048910 |
| Premarket submissions | P040046 |
| Product codes | FTR |
| Device names | FTR - Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled |
| Device class | Class III |
| Classification regulations (21 CFR) | 878.3540 |
| Review panels | General & Plastic Surgery |
| Registered establishments | PRO-TECH Design & Mfg, Inc. |
| Establishment registrations | 3010531069 |
| FEI numbers | 3010531069 |
| Establishment operations | Repackager/Relabeler |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 100–999 UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database