FDA device listing
Amplia MRI CRT-D SureScan,Amplia MRI Quad CRT-D SureScan,Brava,Brava Quadripolar CRT-D,Claria MRI CRT-D,Claria MRI Quad…
FDA device listing 2051129662 · Medtronic, Inc.
Key facts
| Proprietary names | Amplia MRI CRT-D SureScan,Amplia MRI Quad CRT-D SureScan,Brava,Brava Quadripolar CRT-D,Claria MRI CRT-D,Claria MRI Quad CRT-D,Cobalt HF CRT-D MRI SureScan,Cobalt HF Quad CRT-D MRI SureScan,Cobalt XT HF CRT-D MRI SureScan,Cobalt XT HF Quad CRT-D MRI SureScan,Compia MRI CRT-D SureScan,Compia MRI Quad CRT-D SureScan,Concerto ICD,Concerto II CRT-D,Consulta DF4 ICD,Consulta ICD,Crome HF CRT-D MRI… |
|---|---|
| Owner/operator | Medtronic, Inc. |
| Owner/operator number | 2112641 |
| Premarket submissions | P010031 |
| Product codes | KRG, LWS, NIK, NKE, NVZ, OSR |
| Device names | KRG - Programmer, Pacemaker, LWS - Implantable Cardioverter Defibrillator (Non-Crt), NIK - Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D), NKE - Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P), NVZ - Pulse Generator, Permanent, Implantable, OSR - Pacemaker/Icd/Crt Non-Implanted Components |
| Device class | Class III |
| Classification regulations (21 CFR) | 870.3700, ORCA1.LWS, ORCA1.NIK, ORCA1.NKE, ORCA1.NVZ, ORCA1.OSR |
| Review panels | Cardiovascular |
| Registered establishments | Medtronic Distribution Center, Medtronic Engineering and Innovation Center (MEIC), Medtronic Europe Sarl, MEDTRONIC, INC., MEDTRONIC SOFAMOR DANEK USA, INC. |
| Establishment registrations | 2182208, 9614453, 3003120897, 3009380063, 3018094310 |
| FEI numbers | 2182208, 3002807576, 3003120897, 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