ApprovalTrail

Medical device licence · 111482 · Class 2

CANNULATING SPHINCTEROTOME

Yes: licensed in Canada

Licence status Issued (active); first licensed July 8, 2024. It is in Health Canada’s list of active licences.
Licence number
111482
Licence holder
Boston Scientific CorporationWatertown, MA, United States
Risk class
Class II (low to moderate risk)
Licence type
Device Group Family
First licensed
July 8, 2024
Devices covered
7

Devices on this licence

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

  • AUTOTOME PRO RX 39 SPHINCTEROTOME
  • AUTOTOME PRO RX 44 SPHINCTEROTOME
  • DREAMTOME PRO RX 44 SPHINCTEROTOME
  • HYDRATOME PRO RX 44 SPHINCTEROTOME
  • JAGTOME PRO RX 39 SPHINCTEROTOME
  • JAGTOME PRO RX 44 SPHINCTEROTOME
  • JAGTOME REVOLUTION PRO RX 39 SPHINCTEROTOME

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