ApprovalTrail

Medical device licence · 36634 · Class 4

HELISTENT

No longer licensed: cancelled: quality-system requirement (2003)

Licence status Cancelled: quality-system requirement (2003); first licensed March 7, 2002; ended February 16, 2004. It is in Health Canada’s archive of licences no longer in force.
Licence number
36634
Licence holder
HexacathRueil-Malmaison, France
Risk class
Class IV (highest risk)
Licence type
Device Family
First licensed
March 7, 2002
Ended
February 16, 2004
Devices covered
2

Devices on this licence

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

  • HELISTENT CORONARY STENT
  • HELISTENT PREMOUNTED CORONARY STENT

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