AudioStream and AudioKey 2.0
FDA premarket approval P000025/S117 · decided 2020-09-25
Approval details
- PMA number
- P000025
- Supplement
- S117
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- AudioStream and AudioKey 2.0
- Generic name
- Implant, cochlear
- Applicant
- Med-El Corp.
- Date received
- 2020-06-29
- Decision date
- 2020-09-25
- Days to decision
- 88 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Innsbruck
- 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.
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