Medical device licence · 97836 · Class 2
DELIVERY CATHETER SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed October 13, 2016. It is in Health Canada’s list of active licences.
- Licence number
- 97836
- Licence holder
- Medtronic Corevalve LlcSanta Ana, CA, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Family
- First licensed
- October 13, 2016
- Devices covered
- 4
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ENVEO PRO DELIVERY CATHETER SYSTEM
- ENVEO R DELIVERY CATHETER SYSTEM
- EVOLUT FX DELIVERY CATHETER SYSTEM
- EVOLUT PRO+ DELIVERY CATHETER SYSTEM
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.