FDA device listing
Attain,Attain Bipolar OTW Lead,Attain OTW,CareLink SmartSync Percepta, Solera, Serena Application,Consulta…
FDA device listing 1950599349 · Medtronic, Inc.
Key facts
| Proprietary names | Attain,Attain Bipolar OTW Lead,Attain OTW,CareLink SmartSync Percepta, Solera, Serena Application,Consulta CRT-P,Insync,Percepta CRT-P MRI SureScan,Percepta Quad CRT-P MRI SureScan,Serena CRT-P MRI SureScan,Serena Quad CRT-P MRI SureScan,Solara CRT-P MRI SureScan,Solara Quad CRT-P MRI SureScan,Syncra CRT-P,Viva CRT-P |
|---|---|
| Owner/operator | Medtronic, Inc. |
| Owner/operator number | 2112641 |
| Premarket submissions | P010015 |
| Product codes | LWP, NKE, NVZ, OJX |
| Device names | LWP - Implantable Pulse Generator, Pacemaker (Non-Crt), NKE - Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P), NVZ - Pulse Generator, Permanent, Implantable, OJX - Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode |
| Device class | Class III |
| Classification regulations (21 CFR) | ORCA1.LWP, ORCA1.NKE, ORCA1.NVZ, ORCA1.OJX |
| 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 VASCULAR |
| Establishment registrations | 1220452, 2182208, 2649622, 9614453, 3009380063, 3018094310 |
| FEI numbers | 1220452, 2182208, 2649622, 3002807576, 3009380063, 3018094310 |
| Establishment operations | Complaint File Establishment, 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