ApprovalTrail

Medical device licence · 37916 · Class 2

PACEART SYSTEM

Yes: licensed in Canada

Licence status Issued (active); first licensed May 6, 2002. It is in Health Canada’s list of active licences.
Licence number
37916
Licence holder
Medtronic Inc.Minneapolis, MN, United States
Risk class
Class II (low to moderate risk)
Licence type
System
First licensed
May 6, 2002
Devices covered
6

Devices on this licence

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

  • PACEART SYSTEM 12 LEAD MODULE
  • PACEART SYSTEM AUXILARY MODULE
  • PACEART SYSTEM CABLE
  • PACEART SYSTEM CARDIOVOICE SOFTWARE
  • PACEART SYSTEM HEART ACCESS 3500 FOR TRANSTELEPHONIC TRANSMISSION
  • PACEART SYSTEM SOFTWARE

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