FDA device listing
Implantable Pulse Generator
FDA device listing 1065440017 · GREATBATCH MEDICAL
Key facts
| Owner/operator | GREATBATCH MEDICAL |
|---|---|
| Owner/operator number | 9035261 |
| Product codes | QFV |
| Device names | QFV - Implantable Pulse Generator |
| Device class | Class III |
| Classification regulations (21 CFR) | ORCA1.QFV |
| Review panels | Cardiovascular |
| Registered establishments | Centro de Construccion de Cardioestimuladores del Uruguay S.A., Greatbatch Medical S. de R.L. de C.V. |
| Establishment registrations | 3010326622, 3011823740 |
| FEI numbers | 3010326622, 3011823740 |
| Establishment operations | Contract Manufacturer, Contract Sterilizer |
| 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