Medical device licence · 96499 · Class 3
SPACEOAR SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed February 5, 2016. It is in Health Canada’s list of active licences.
- Licence number
- 96499
- Licence holder
- Boston Scientific CorporationWatertown, MA, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- Device Group Family
- First licensed
- February 5, 2016
- Devices covered
- 1
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- SPACEOAR SYSTEM
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 “spaceoar”. A notice may cover another product or only some lots: read it to see what it covers.
- Spaceoar SystemMarch 7, 2022 · Orthopaedics · Revised instructions for use · Type II
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.