FDA device listing
CONTAK RENEWAL TR Software Application,INTUA,INVIVE,VALITUDE,VALITUDE X4,VISIONIST,VISIONIST X4
FDA device listing 1069547642 · Boston Scientific Corporation
Key facts
| Proprietary names | CONTAK RENEWAL TR Software Application,INTUA,INVIVE,VALITUDE,VALITUDE X4,VISIONIST,VISIONIST X4 |
|---|---|
| Owner/operator | Boston Scientific Corporation |
| Owner/operator number | 9912058 |
| Premarket submissions | P030005 |
| Product codes | DTB, NKE, OSR |
| Device names | DTB - Permanent Pacemaker Electrode, NKE - Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P), OSR - Pacemaker/Icd/Crt Non-Implanted Components |
| Device class | Class III |
| Classification regulations (21 CFR) | 870.3680, ORCA1.NKE, ORCA1.OSR |
| Review panels | Cardiovascular |
| Registered establishments | Boston Scientific Corporation, Boston Scientific Limited |
| Establishment registrations | 2124215, 9616693 |
| FEI numbers | 2124215, 3002618605 |
| Establishment operations | Complaint File Establishment, Manufacturer, Specification Developer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 1–9 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