FDA device listing
Fantom Encore
FDA device listing 1667063742 · REVA Medical, LLC
Key facts
| Proprietary names | Fantom Encore |
|---|---|
| Owner/operator | REVA Medical, LLC |
| Owner/operator number | 10081046 |
| Product codes | PNY |
| Device names | PNY - Absorbable Coronary Drug-Eluting Stent |
| Device class | Class III |
| Classification regulations (21 CFR) | ORCA1.PNY |
| Review panels | Cardiovascular |
| Registered establishments | REVA MEDICAL, LLC |
| Establishment registrations | 3003600556 |
| FEI numbers | 3003600556 |
| Establishment operations | U.S. Manufacturer of Export Only Devices |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None listed 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