Medical device licence · 91350 · Class 4
OPTISURE DEFIBRILLATION LEAD
Yes: licensed in Canada
Licence status Issued (active); first licensed May 17, 2013. It is in Health Canada’s list of active licences.
- Licence number
- 91350
- Licence holder
- Abbott MedicalPlymouth, MN, United States
- Risk class
- Class IV (highest risk)
- Licence type
- Device Group Family
- First licensed
- May 17, 2013
- Devices covered
- 3
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- OPTISURE DEFIBRILLATION LEAD 58CM
- OPTISURE DEFIBRILLATION LEAD 60CM
- OPTISURE DEFIBRILLATION LEAD 65CM
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 “optisure”. A notice may cover another product or only some lots: read it to see what it covers.
- OPTISURE DEFIBRILLATION LEAD (ACTIVE FIXATION) (2015-11-02)November 2, 2015 · Medical devices · Health products · Type II
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.