FDA device listing
St Jude Medical MR Conditional Pacemaker System,Zenex MRI PM1283,Zenex MRI PM2283
FDA device listing 2051987943 · ABBOTT LABORATORIES
Key facts
| Proprietary names | St Jude Medical MR Conditional Pacemaker System,Zenex MRI PM1283,Zenex MRI PM2283 |
|---|---|
| Owner/operator | ABBOTT LABORATORIES |
| Owner/operator number | 1415939 |
| Premarket submissions | P140033 |
| Product codes | DXY, LWP, NVN |
| Device names | DXY - Implantable Pacemaker Pulse-Generator, LWP - Implantable Pulse Generator, Pacemaker (Non-Crt), NVN - Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes |
| Device class | Class III |
| Classification regulations (21 CFR) | 870.3610, ORCA1.LWP, ORCA1.NVN |
| Review panels | Cardiovascular |
| Registered establishments | Abbott Medical, ABBOTT MEDICAL |
| Establishment registrations | 2017865, 3006705815, 3008494315, 3013288201 |
| FEI numbers | 2017865, 3006705815, 3008377825, 3013288201 |
| Establishment operations | Complaint File Establishment, Manufacturer |
| 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