Medical device licence · 98985 · Class 4
CARELINK ENCORE
Yes: licensed in Canada
Licence status Issued (active); first licensed April 20, 2017. It is in Health Canada’s list of active licences.
- Licence number
- 98985
- Licence holder
- Medtronic Inc.Minneapolis, MN, United States
- Risk class
- Class IV (highest risk)
- Licence type
- System
- First licensed
- April 20, 2017
- Devices covered
- 31
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ADAPTA, VERSA, SENSIA PULSE GENERATORS PROGRAMMING SOFTWARE
- APPLICATION SOFTWARE (FOR VIVA, BRAVA, EVERA)
- ATTESTA MRI SURESCAN / SPHERA MRI SURESCAN
- BOSS (SW028)
- CARELINK ENCORE PROGRAMMER
- CARELINK ENCORE PROGRAMMER HEAD
- CONCERTO, VIRTUOSO SOFTWARE
- CONSULTA / SECURA / MAXIMO II / CONCERTO II / ADVISA / ENSURA / SYNCRA / VIVA CRT-P SOFTWARE
- CRT-D MRI SOFTWARE
- ENPULSE SOFTWARE
- ENRHYTHM (MODEL 9987)
- ENTRUST SOFTWARE
- INSYNC III ATRIAL SYNCHRONOUS BIVENTRICULAR PACING DEVICE SOFTWARE
- INSYNC III PROTECT - SOFTWARE
- KAPPA 700/600 SOFTWARE
- MARQUIS DR SOFTWARE
- MARQUIS VR SOFTWARE
- MAXIMO DR/VR SOFTWARE
- MEDTRONIC VISION KAPPA 900/800 SOFTWARE
- PROTECTA/PROTECTA XT/CARDIA/EGIDA SOFTWARE
- RELIA SOFTWARE
- REVEAL XT INSERTABLE CARDIAC MONITOR - SOFTWARE
- SIGMA PACEMAKER SYSTEM - SOFTWARE
- SOFTWARE SW035
- SW022 MRI SOFTWARE
- SW026 SOFTWARE
- SW030 SOFTWARE
- SW033 SOFTWARE
- SW040 SOFTWARE
- SW041 SOFTWARE
- SW044 SOFTWARE
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
- CareLink 2090 Programmer and CareLink Encore 29901 Programmer (2018-10-08)November 2, 2018 · Medical devices · Medical devices · Type II
- IPRO CARELINK THERAPY MANAGEMENT SOFTWARE (2017-10-10)November 10, 2017 · 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.