Medical device licence · 79487 · Class 2
ASCENDRA INTRODUCER SHEATH SET
No longer licensed: discontinued at renewal
Licence status Discontinued at renewal; first licensed April 9, 2009; ended October 25, 2017. It is in Health Canada’s archive of licences no longer in force.
- Licence number
- 79487
- Licence holder
- Edwards Lifesciences LlcIrvine, CA, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Group
- First licensed
- April 9, 2009
- Ended
- October 25, 2017
- Devices covered
- 1
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ASCENDRA INTRODUCER SHEATH SET
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 “ascendra”. A notice may cover another product or only some lots: read it to see what it covers.
- Sapien XT Transcatheter with Ascendra Delivery System and Edwards Sapien XT Transcatheter with Novaflex Delivery System (2013-04-17)May 8, 2014 · Medical devices · Medical devices · Type III
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.