Reveal LINQ™, Reveal® LNQ11
Listed
Valid until
Not applicable
FDA recalls
None ongoingDocuments
None
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00643169547940 | Date10 Jun 2015 | StatusListed |
Recalls
-
- Terminated Z-1249-2016
Medtronic has identified an issue with the sensitivity of an algorithm used in the Reveal LINQ ICM that may prematurely trigger the Recommended Replacement Time (RRT) alert in some devices. Battery capacity is not affected and the device will continue to support data collection and manual data transmissions. As part of the normal behavior of the device, 30 days after RRT status is reached, Reveal
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade Name
- Reveal LINQ™, Reveal®
- Generic Name
- Implantable cardiac monitor
- Model / Reference
- LNQ11
- Primary DI / UDI-DI
- 00643169547940
- 510(k) Number
- FDA Product Code
- DSI
- GMDN Term
- Implantable cardiac monitor
- Device Class
- Class II
- Regulation Number
- 870.1025
- GUDID distribution status
- Not in Commercial Distribution
- MRI Safety
- MR Conditional
Other devices from Medtronic, Inc.
Properties
Other properties (9)
- Contains Latex: No
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Premarket Exempt: No
- Lot / Batch Number: No
- Expiration Date: No
- Manufacturing Date: No