Medical device licence · 84013 · Class 4
MERLIN PACING SYSTEM ANALYZER (PSA) SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed September 30, 2010. It is in Health Canada’s list of active licences.
- Licence number
- 84013
- Licence holder
- St. Jude Medical, Cardiac Rhythm Management DivisionSylmar, CA, United States
- Risk class
- Class IV (highest risk)
- Licence type
- System
- First licensed
- September 30, 2010
- Devices covered
- 4
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- MERLIN PSA (PACING SYSTEM ANALYZER) - "M" ADAPTER
- MERLIN PSA (PACING SYSTEM ANALYZER) - ANALYZER
- MERLIN PSA (PACING SYSTEM ANALYZER) - ANTENNA ADAPTER
- MERLIN PSA (PACING SYSTEM ANALYZER) - CABLE ADAPTER
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.