Medical device licence · 94430 · Class 3
ARGUS II RETINAL PROSTHESIS SYSTEM
No longer licensed: suspended: invalid quality-system certificate
Licence status Suspended: invalid quality-system certificate; first licensed December 23, 2014; ended July 29, 2019. It is in Health Canada’s archive of licences no longer in force.
- Licence number
- 94430
- Licence holder
- Second Sight Medical Products, Inc.Sylmar, CA, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- December 23, 2014
- Ended
- July 29, 2019
- Devices covered
- 18
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ARGUS II ARCHIVE DRIVE
- ARGUS II CABLE
- ARGUS II CLINICIAN FITTING SYSTEM
- ARGUS II COMMUNICATION ADAPTER
- ARGUS II GLASSES
- ARGUS II OPERATING ROOM COIL
- ARGUS II PYSCHOLOGICAL TEST SYSTEM
- ARGUS II RETINAL PROSTHESIS KIT
- ARGUS II RETINAL TACK
- ARGUS II TOUCH SCREEN MONITOR
- ARGUS II USB DATA TRANSFER DRIVE
- ARGUS II USB SECURITY DRIVE
- ARGUS II USB VIDEO SETTING DRIVE
- ARGUS II VIDEO PROCESSING UNIT
- ARGUS II VPU IMPLANT MATCHING CD
- BATTERY CHARGER
- SOFTWARE SUITE, SWIFT PROGRAMMING ASSISTANT, ARGUS II
- VPU RECHARGEABLE BATTERY
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.