ApprovalTrail

Medical device licence · 99246 · Class 2

FFR LINK (FFR SIGNAL PROCESSING MODULE)

Yes: licensed in Canada

Licence status Issued (active); first licensed May 30, 2017. It is in Health Canada’s list of active licences.
Licence number
99246
Licence holder
Boston Scientific CorporationWatertown, MA, United States
Risk class
Class II (low to moderate risk)
Licence type
System
First licensed
May 30, 2017
Devices covered
5

Devices on this licence

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

  • CABLE ADAPTER KIT SIEMENS 10P/DRAEGER 7P
  • CABLE, PD OUT
  • FFR LINK
  • FFR LINK BLUETOOTH COMMUNICATION MODULE
  • IBP CABLE KIT

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