FDA device listing
Implantable Pacemaker Pulse-Generator
FDA device listing 1998545310 · BENCHMARK ELECTRONICS, INC.
Key facts
| Owner/operator | BENCHMARK ELECTRONICS, INC. |
|---|---|
| Owner/operator number | 1641405 |
| Product codes | DXY, LWP, LWS, NIK, NKE |
| Device names | DXY - Implantable Pacemaker Pulse-Generator, LWP - Implantable Pulse Generator, Pacemaker (Non-Crt), 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) |
| Device class | Class III |
| Classification regulations (21 CFR) | 870.3610, ORCA1.LWP, ORCA1.LWS, ORCA1.NIK, ORCA1.NKE |
| Review panels | Cardiovascular |
| Registered establishments | BENCHMARK ELECTRONICS, INC. |
| Establishment registrations | 2133641 |
| FEI numbers | 3000203466 |
| Establishment operations | Contract Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None listed 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