Medical device licence · 107649 · Class 4
AVEIR LEADLESS PACEMAKER
Yes: licensed in Canada
Licence status Issued with conditions; first licensed April 22, 2022. It is in Health Canada’s list of active licences.
- Licence number
- 107649
- Licence holder
- Abbott MedicalPlymouth, MN, United States
- Risk class
- Class IV (highest risk)
- Licence type
- Single Device
- First licensed
- April 22, 2022
- Devices covered
- 2
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- AVEIR AR 2 LEADLESS PACEMAKER
- AVEIR LEADLESS PACEMAKER
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 “aveir”. A notice may cover another product or only some lots: read it to see what it covers.
- Aveir™ Leadless PacemakerAugust 19, 2024 · Cardiovascular · Device compatibility · Type II
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.