Medical device licence · 76660 · Class 3
ESTEEM IMPLANTABLE HEARING SYSTEM
No longer licensed: cancelled: renewal not answered
Licence status Cancelled: renewal not answered; first licensed March 31, 2008; ended October 31, 2013. It is in Health Canada’s archive of licences no longer in force.
- Licence number
- 76660
- Licence holder
- Envoy Medical CorporationSt. Paul, MN, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- March 31, 2008
- Ended
- October 31, 2013
- Devices covered
- 15
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ESTEEM IMPLANTABLE HEARING SYSTEM - COMMANDER PROGRAMMER
- ESTEEM IMPLANTABLE HEARING SYSTEM - DRIVER
- ESTEEM IMPLANTABLE HEARING SYSTEM - EAR INSERT ASSEMBLY
- ESTEEM IMPLANTABLE HEARING SYSTEM - ENVOYCEM
- ESTEEM IMPLANTABLE HEARING SYSTEM - GLASSCOCK STABILIZER
- ESTEEM IMPLANTABLE HEARING SYSTEM - INTRAOPERATIVE SYSTEM ANALYZER
- ESTEEM IMPLANTABLE HEARING SYSTEM - MEDCEM
- ESTEEM IMPLANTABLE HEARING SYSTEM - PERSONAL PROGRAMMER
- ESTEEM IMPLANTABLE HEARING SYSTEM - PROGRAMMER SOFTWARE
- ESTEEM IMPLANTABLE HEARING SYSTEM - REPLICA SOUND PROCESSOR
- ESTEEM IMPLANTABLE HEARING SYSTEM - SENSOR
- ESTEEM IMPLANTABLE HEARING SYSTEM - SOUND PROCESSOR
- ESTEEM IMPLANTABLE HEARING SYSTEM - STANDARD SURGICAL ACCESSORY KIT
- ESTEEM IMPLANTABLE HEARING SYSTEM - WAND
- ESTEEM IMPLANTABLE HEARING SYSTEM - WAND SLEEVE
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.