COMBI 40+ COCHLEAR IMPLANT SYSTEM
FDA premarket approval P000025/S077 · decided 2014-06-24
Approval details
- PMA number
- P000025
- Supplement
- S077
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- COMBI 40+ COCHLEAR IMPLANT SYSTEM
- Generic name
- Implant, cochlear
- Applicant
- Med-El Corp.
- Date received
- 2014-04-03
- Decision date
- 2014-06-24
- Days to decision
- 82 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Innsbruck
- Statement
- APPROVAL FOR THE MAX PROGRAMMING INTERFACE AND THE ASSOCIATEDMAESTRO 5.0 PROGRAMMING SOFTWARE UPDATE.
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