ApprovalTrail

Medical device licence · 109357 · Class 4

ETERNA IMPLANTABLE PULSE GENERATOR

Yes: licensed in Canada

Licence status Issued (active); first licensed May 19, 2023. It is in Health Canada’s list of active licences.
Licence number
109357
Licence holder
Abbott MedicalPlymouth, MN, United States
Risk class
Class IV (highest risk)
Licence type
System
First licensed
May 19, 2023
Devices covered
5

Devices on this licence

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

  • CHARGER
  • ETERNA IMPLANTABLE PULSE GENERATOR
  • PATIENT MAGNET
  • PORT PLUG
  • SCS CHARGING SYSTEM

Recalls and safety alerts that mention it

Health Canada’s recall notices do not carry licence numbers, so these are matched by name: notices whose title or product names “eterna”. A notice may cover another product or only some lots: read it to see what it covers.

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