Medical device licence · 105122 · Class 4
PROCLAIM IMPLANTABLE PULSE GENERATORS
Yes: licensed in Canada
Licence status Issued (active); first licensed September 14, 2020. It is in Health Canada’s list of active licences.
- Licence number
- 105122
- Licence holder
- Abbott MedicalPlymouth, MN, United States
- Risk class
- Class IV (highest risk)
- Licence type
- Device Group Family
- First licensed
- September 14, 2020
- Devices covered
- 4
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- PROCLAIM 5 IMPLANTABLE PULSE GENERATOR
- PROCLAIM 7 IMPLANTABLE PULSE GENERATOR
- PROCLAIM XR 5 IMPLANTABLE PULSE GENERATOR
- PROCLAIM XR 7 IMPLANTABLE PULSE GENERATOR
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 “proclaim”. A notice may cover another product or only some lots: read it to see what it covers.
- Abbott's Proclaim™ SCS/Proclaim™ DRG/Infinity™ DBS Implantable Pulse GeneratorsApril 30, 2026 · Neurology - Anaesthesiology · Device compatibility - Performance · Type II
- Proclaim Implantable Pulse GeneratorsJuly 4, 2024 · Anaesthesiology - Neurology · Labelling and packaging - Performance · Type II
- Proclaim and Infinity Implantable Pulse GeneratorsAugust 15, 2023 · Anaesthesiology - Neurology · Performance · Type II
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.