Medical device licence · 10446 · Class 4
INSYNC SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed August 24, 1999. It is in Health Canada’s list of active licences.
- Licence number
- 10446
- Licence holder
- Medtronic Inc.Minneapolis, MN, United States
- Risk class
- Class IV (highest risk)
- Licence type
- System
- First licensed
- August 24, 1999
- Devices covered
- 3
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- CORONARY SINUS LEAD (UNIPOLAR AND BIPOLAR)
- INSYNC SYSTEM - MULTISITE, MULTICHAMBER PULSE GENERATOR
- INSYNC SYSTEM - SOFTWARE MODEL 9980
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 “insync”. A notice may cover another product or only some lots: read it to see what it covers.
- INSYNC III ATRIAL SYNCHRONOUS BIVENTRICULAR PACING DEVICE (2015-11-09)November 9, 2015 · Medical devices · Health products · Type I
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.