CareLink SmartSync™ Azure Astra Application
SW D00U003 SS Azure Astra
1manufacturer
1catalogue number
Who Else Makes It
Registered in Guangdong. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amphenol Alden Products Company | Shenzhen | Guangdong | Contract manufacturer | 24 |
Record
| Listed by | Medtronic, Inc., United States |
|---|---|
| FDA product code | DTC |
| Device type | Analyzer, Pacemaker Generator Function |
| Device class | Class 2 |
| Regulation | 21 CFR 870.3630 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| 510(k) | P980035 |
| Record published | 2019-04-06 |
| Record revised | 2019-07-02 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| D00U003 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| External Pacemaker Analyzer | Netech Corp. | 2 |
| CareLink SmartSync™ Common Application | Medtronic, Inc. | 2 |
| PK-141/2.8m | Biotronik SE & Co. KG | 1 |
| CareLink SmartSync™ | Medtronic, Inc. | 1 |
| External Pacemaker Ananlyzer | Netech Corp. | 1 |
| SigmaPace 1000 | Fluke Electronics Corporation | 1 |
| Analyzer, Pacemaker Generator Function | Boston Scientific Corporation | 1 |
Recalls Naming This Product
4 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Medtronic, Inc. | UDI-DI | 2025-06-18 | Class II | Software design | In prior SmartSync application versions, the Abort button stopped the test that was selected. During an induction test, there was a limited window of time for the user to abort a therapy, thereby limiting the user’s ability to cancel a high | 22091 total devices |
| Medtronic, Inc. | UDI-DI | 2025-06-18 | Class II | Software design | In prior SmartSync application versions, the Abort button stopped the test that was selected. During an induction test, there was a limited window of time for the user to abort a therapy, thereby limiting the user’s ability to cancel a high | 22091 total devices |
| Medtronic, Inc. | UDI-DI | 2025-06-17 | Class II | Software design | A software update for Medtronic CareLink SmartSync Device Manager (SmartSync) is now available. The update eliminates the potential display of an erroneous electrical reset (pop-up) message upon interrogation with a SmartSync Device Manage | 3909 units |
| Medtronic, Inc. | UDI-DI | 2025-06-17 | Class II | Software design | A software update for Medtronic CareLink SmartSync Device Manager (SmartSync) is now available. The update eliminates the potential display of an erroneous electrical reset (pop-up) message upon interrogation with a SmartSync Device Manage | 5418 units |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.