PMA P000025S117
- Device
- AudioStream and AudioKey 2.0
- Applicant
- Med-El Corp.
- Product code
- MCM
- Decision date
- 2020-09-25
- Generic name
- Implant, cochlear
- Approval order statement
- Approval for AudioStream, an alternative battery pack cover and AudioKey 2.0, a mobile application, used with compatible audio processors of the Med-El cochlear implant system.
Current openFDA PMA Record#
- Device
- AudioStream and AudioKey 2.0
- Applicant
- Med-El Corp.
- PMA number
- P000025
- Supplement
- S117
- Product code
- MCM
- Generic name
- Implant, cochlear
- Decision date
- 2020-09-25
- Decision code
- APPR
- Date received
- 2020-06-29
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for AudioStream, an alternative battery pack cover and AudioKey 2.0, a mobile application, used with compatible audio processors of the Med-El cochlear implant system.