FDA device listing
Edwards Pericardial Aortic Bioprosthesis,INSPIRIS 11500A (RESILIA Process),INSPIRIS RESILIA Aortic Valve,MITRIS RESILIA…
FDA device listing 1116815368 · Sotera Health LLC
Key facts
| Proprietary names | Edwards Pericardial Aortic Bioprosthesis,INSPIRIS 11500A (RESILIA Process),INSPIRIS RESILIA Aortic Valve,MITRIS RESILIA Mitral Valve |
|---|---|
| Owner/operator | Sotera Health LLC |
| Owner/operator number | 10029425 |
| Product codes | LWR |
| Device names | LWR - Heart-Valve, Non-Allograft Tissue |
| Device class | Class III |
| Classification regulations (21 CFR) | ORCA1.LWR |
| Review panels | Cardiovascular |
| Registered establishments | Sterigenics Costa Rica S.R.L., Sterigenics US LLC |
| Establishment registrations | 2011171, 3010432890 |
| FEI numbers | 2011171, 3010432890 |
| Establishment operations | Contract Sterilizer |
| 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