MED-EL COCHLEAR IMPLANT SYSTEM
FDA premarket approval P000025/S081 · decided 2015-03-11
Approval details
- PMA number
- P000025
- Supplement
- S081
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MED-EL COCHLEAR IMPLANT SYSTEM
- Generic name
- Implant, cochlear
- Applicant
- Med-El Corp.
- Date received
- 2014-12-11
- Decision date
- 2015-03-11
- Days to decision
- 90 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Innsbruck
- Statement
- APPROVAL FOR THE DL-COIL, AN EXTERNAL AUDIO PROCESSOR COIL FOR USE WITH THE MED-EL COCHLEAR IMPLANT, AS PART OF THE COMBI 40+ COCHLEAR IMPLANT SYSTEM.
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