FDA device listing
Ace Header Emulator,End Cap,Epicardial Patch Lead,GEM,GEM VR,Lead Patch,MICRO JEWEL,MICRO JEWEL II,Patient Cable,Patient…
FDA device listing 1528776185 · Medtronic, Inc.
Key facts
| Proprietary names | Ace Header Emulator,End Cap,Epicardial Patch Lead,GEM,GEM VR,Lead Patch,MICRO JEWEL,MICRO JEWEL II,Patient Cable,Patient Magnet,PCD,Sizing Sleeve,Upsizing Sleeve |
|---|---|
| Owner/operator | Medtronic, Inc. |
| Owner/operator number | 2112641 |
| Premarket submissions | P900061 |
| Product codes | LWS |
| Device names | LWS - Implantable Cardioverter Defibrillator (Non-Crt) |
| Device class | Class III |
| Classification regulations (21 CFR) | ORCA1.LWS |
| Review panels | Cardiovascular |
| Registered establishments | Medtronic Distribution Center, Medtronic Europe Sarl, Medtronic, Inc., MEDTRONIC, INC., MEDTRONIC PUERTO RICO OPERATIONS CO., VILLALBA |
| Establishment registrations | 2182208, 2649622, 9614453, 3009380063, 3015544746 |
| FEI numbers | 2182208, 2649622, 3002807576, 3009380063, 3015544746 |
| Establishment operations | Manufacturer, Repackager/Relabeler, Specification Developer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 10–99 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