FDA device listing
Access Review Therapy Controller,Access Therapy Controller,Activa PC Neurostimulator,Activa SC Neurostimulator,DBS…
FDA device listing 1456529414 · Medtronic, Inc.
Key facts
| Proprietary names | Access Review Therapy Controller,Access Therapy Controller,Activa PC Neurostimulator,Activa SC Neurostimulator,DBS Extension Kit,N'Vision Programmer,N'Vision Software Application Card,Percept™ PC BrainSense™,Reclaim Deep Brain Stimulation |
|---|---|
| Owner/operator | Medtronic, Inc. |
| Owner/operator number | 2112641 |
| Premarket submissions | H050003 |
| Product codes | MFR, OLM |
| Device names | MFR - Stimulator, Brain, Implanted, For Behavior Modification, OLM - Deep Brain Stimulator For Obsessive Compulsive Disorder (Ocd) |
| Device class | HDE |
| Classification regulations (21 CFR) | ORCA1.MFR, ORCA1.OLM |
| Review panels | Neurology |
| Registered establishments | Medtronic Distribution Center, Medtronic Engineering and Innovation Center (MEIC), MEDTRONIC NEUROMODULATION, MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS, MEDTRONIC PUERTO RICO OPERATIONS CO., VILLALBA |
| Establishment registrations | 2182207, 2649622, 3004209178, 3009380063, 3018094310 |
| FEI numbers | 2182207, 2649622, 3004369318, 3009380063, 3018094310 |
| Establishment operations | Complaint File Establishment, Manufacturer, Repackager/Relabeler |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 100–999 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