Medical device licence · 83679 · Class 3
PONTO BONE ANCHORED HEARING SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed August 20, 2010. It is in Health Canada’s list of active licences.
- Licence number
- 83679
- Licence holder
- Oticon Medical AbAskim, Sweden
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- August 20, 2010
- Devices covered
- 17
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ABUTMENT
- ABUTMENT INSERTER, MACHINE
- COVER SCREW HEXAGON
- GUIDE DRILL
- MIPS SURGERY KIT
- MONO SURGERY KIT
- PONTO 3 POWER, SOUND PROCESSOR
- PONTO 3 SUPERPOWER
- PONTO 3, SOUND PROCESSOR
- PONTO 4
- PONTO 5 MINI
- PONTO BHX IMPLANT
- SCREWDRIVER, MACHINE
- SQUARE FIT CONNECTION, MACHINE
- WIDE COUNTERSINK
- WIDE IMPLANT
- WIDE IMPLANT WITH ABUTMENT
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.