ApprovalTrail

Medical device licence · 74175 · Class 4

IMPELLA CIRCULATORY SUPPORT SYSTEM

Yes: licensed in Canada

Licence status Issued (active); first licensed June 28, 2007. It is in Health Canada’s list of active licences.
Licence number
74175
Licence holder
Abiomed Inc.Danvers, MA, United States
Risk class
Class IV (highest risk)
Licence type
System
First licensed
June 28, 2007
Devices covered
10

Devices on this licence

By name, as listed. The official record lists model numbers and identifiers.

  • AIC SOFTWARE
  • AUTOMATED IMPELLA CONTROLLER
  • AXILLARY INSERTION KIT FOR IMPELLA 5.0
  • GUIDEWIRES
  • IMPELLA 5.5 SET WITH SMARTASSIST
  • IMPELLA 5.5 WITH SMARTASSIST
  • IMPELLA 5.5 WITH SMARTASSIST CATHETER
  • IMPELLA CIRCULATORY SUPPORT SYSTEM - IMPELLA CP WITH SMART ASSIST
  • IMPELLA CP INTRODUCER KIT
  • IMPELLA PURGE CASSETTE

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 “impella”. A notice may cover another product or only some lots: read it to see what it covers.

Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.