Medical device licence · 95034 · Class 4
PRODIGY NEUROSTIMULATION SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed April 21, 2015. It is in Health Canada’s list of active licences.
- Licence number
- 95034
- Licence holder
- Abbott MedicalPlymouth, MN, United States
- Risk class
- Class IV (highest risk)
- Licence type
- System
- First licensed
- April 21, 2015
- Devices covered
- 6
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- BATTERY PACK
- COMMUNICATION WAND
- PATIENT MAGNET
- PRODIGY CHARGING SYSTEM
- PRODIGY IMPLANTABLE PULSE GENERATOR (IPG)
- PRODIGY PATIENT PROGRAMMER
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.