FDA device listing
CapSureFix MRI SureScan Lead,Revo MRI SureScan
FDA device listing 1410889433 · Medtronic, Inc.
Key facts
| Proprietary names | CapSureFix MRI SureScan Lead,Revo MRI SureScan |
|---|---|
| Owner/operator | Medtronic, Inc. |
| Owner/operator number | 2112641 |
| Premarket submissions | P090013 |
| Product codes | LWP, NVN, NVZ |
| Device names | LWP - Implantable Pulse Generator, Pacemaker (Non-Crt), NVN - Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes, NVZ - Pulse Generator, Permanent, Implantable |
| Device class | Class III |
| Classification regulations (21 CFR) | ORCA1.LWP, ORCA1.NVN, ORCA1.NVZ |
| Review panels | Cardiovascular |
| Registered establishments | Medtronic Distribution Center, Medtronic Engineering and Innovation Center (MEIC), Medtronic Europe Sarl, MEDTRONIC, INC., MEDTRONIC PUERTO RICO OPERATIONS CO., VILLALBA, Medtronic Singapore Operations Pte Ltd, MEDTRONIC SOFAMOR DANEK USA, INC. |
| Establishment registrations | 2182208, 2649622, 9614453, 3003120897, 3008973940, 3009380063, 3018094310 |
| FEI numbers | 2182208, 2649622, 3002807576, 3003120897, 3008973940, 3009380063, 3018094310 |
| Establishment operations | Complaint File Establishment, Manufacturer, Repackager/Relabeler |
| 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