Medical device licence · 102084 · Class 3
CARELINK SMARTSYNC DEVICE MANAGER
Yes: licensed in Canada
Licence status Issued (active); first licensed November 30, 2018. It is in Health Canada’s list of active licences.
- Licence number
- 102084
- Licence holder
- Medtronic Inc.Minneapolis, MN, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- November 30, 2018
- Devices covered
- 20
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- CARELINK SMARTSYNC 24970A
- CARELINK SMARTSYNC ADAPTA VERSA SENSIA APPLICATION
- CARELINK SMARTSYNC AURORA EV-ICD APPLICATION
- CARELINK SMARTSYNC AZURE ASTRA APPLICATION
- CARELINK SMARTSYNC CLARIA AMPLIA COMPIA APPLICATION
- CARELINK SMARTSYNC COBALT CROME APPLICATION
- CARELINK SMARTSYNC COMMON APPLICATION
- CARELINK SMARTSYNC DEVICE MANAGER APPLICATION
- CARELINK SMARTSYNC EVERA MRI APPLICATION
- CARELINK SMARTSYNC LINQ II ICM APPLICATION
- CARELINK SMARTSYNC LINQ II PLATFORM APPLICATION
- CARELINK SMARTSYNC MICRA AV APPLICATION
- CARELINK SMARTSYNC MICRA AV2 APPLICATION
- CARELINK SMARTSYNC MICRA VR APPLICATION
- CARELINK SMARTSYNC MICRA VR2 APPLICATION
- CARELINK SMARTSYNC PERCEPTA SERENA SOLARA APPLICATION
- CARELINK SMARTSYNC PSA APPLICATION
- CARELINK SMARTSYNC VISIA AF APPLICATION
- CARELINK SMARTSYNC VIVA BRAVA EVERA APPLICATION
- CARELINK SMARTSYNC VIVA CONSULTA SYNCRA ADVISA ENSURA APPLICATION
Recalls and safety alerts that mention it
Health Canada’s recall notices do not carry licence numbers, so these are matched by name: notices whose title or product names “carelink”. A notice may cover another product or only some lots: read it to see what it covers.
- CareLink™ SmartSync™ Device ManagerOctober 1, 2026 · General hospital and personal use - Cardiovascular · Performance · Type II
- CareLink™ SoftwareNovember 5, 2025 · General hospital and personal use · Performance · Type II
- CareLink SmartSync™ ApplicationsJune 25, 2025 · General hospital and personal use - Cardiovascular · Performance · Type II
- Carelink ProgrammerAugust 26, 2024 · Cardiovascular · Performance · Type II
- CARELINK SMARTSYNC DEVICE MANAGERNovember 12, 2021 · General hospital and personal use · Software defect · Type II
- CARELINK SMARTSYNC DEVICE MANAGER (2020-12-18)January 7, 2021 · Medical devices · Medical devices · Type II
- Carelink (2020-12-11)December 31, 2020 · Medical devices · Medical devices · Type II
- CareLink Software Suite (2020-10-28)November 27, 2020 · Medical devices · Medical devices · Type II
- CareLink 2090 Programmer (2020-08-27)September 25, 2020 · Medical devices · Medical devices · Type II
- Carelink Programmer System (2019-10-04)November 1, 2019 · Medical devices · Medical devices · Type II
- Medtronic Programmers (CareLink, Encore), Medtronic Micra (2019-01-16)February 8, 2019 · Medical devices · Medical devices · Type II
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.