FDA device listing
Adapta,Adapta L,Adapta S,Advisa DR,Advisa DR MRI SureScan,Advisa SR MRI SureScan,Attesta DR MRI,Attesta L DR MRI,Attesta…
FDA device listing 1232151429 · Medtronic, Inc.
Key facts
| Proprietary names | Adapta,Adapta L,Adapta S,Advisa DR,Advisa DR MRI SureScan,Advisa SR MRI SureScan,Attesta DR MRI,Attesta L DR MRI,Attesta S DR MRI,Attesta SR MRI,Azure S DR MRI,Azure S SR MRI,Azure XT DR MRI,Azure XT SR MRI,CareLink SmartSync Azure Astra Application,InCheck Patient Assistant,Relia IPG,Sensia DR IPG,Sensia IPG,Sphera DR MRI,Sphera L DR MRI,Sphera SR MRI,Versa DR IPG |
|---|---|
| Owner/operator | Medtronic, Inc. |
| Owner/operator number | 2112641 |
| Premarket submissions | P980035 |
| Product codes | DXY, LWP, LWS, NVN, NVZ |
| Device names | DXY - Implantable Pacemaker Pulse-Generator, LWP - Implantable Pulse Generator, Pacemaker (Non-Crt), LWS - Implantable Cardioverter Defibrillator (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) | 870.3610, ORCA1.LWP, ORCA1.LWS, ORCA1.NVN, ORCA1.NVZ |
| Review panels | Cardiovascular |
| Registered establishments | Medtronic Distribution Center, Medtronic Europe Sarl, MEDTRONIC, INC., MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS, Medtronic Singapore Operations Pte Ltd, MEDTRONIC SOFAMOR DANEK USA, INC. |
| Establishment registrations | 2182208, 9614453, 3003120897, 3004209178, 3008973940, 3009380063 |
| FEI numbers | 2182208, 3002807576, 3003120897, 3004369318, 3008973940, 3009380063 |
| 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