ApprovalTrail

Medical device licence · 1766 · Class 4

ORBIS HEART VALVE

No longer licensed: discontinued at renewal

Licence status Discontinued at renewal; first licensed March 5, 1999; ended October 25, 2002. It is in Health Canada’s archive of licences no longer in force.
Licence number
1766
Licence holder
Sulzer Carbomedics Canada LtdCalgary, AB, Canada
Risk class
Class IV (highest risk)
Licence type
Device Family
First licensed
March 5, 1999
Ended
October 25, 2002
Devices covered
5

Devices on this licence

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

  • CARBOMEDICS ORBIS HEART VALVE AORTIC
  • CARBOMEDICS ORBIS HEART VALVE MITRAL
  • CARBOMEDICS ORBIS UNIVERSAL HEART VALVE (AORTIC/MITRAL)
  • CARBOMEDICS ORBIS UNIVERSAL HEART VALVE AORTIC
  • CARBOMEDICS ORBIS UNIVERSAL HEART VALVE MITRAL

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