MedEl EAS System
FDA premarket approval P000025/S115 · decided 2020-10-07
Approval details
- PMA number
- P000025
- Supplement
- S115
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Trade name
- MedEl EAS System
- Generic name
- Implant, cochlear
- Applicant
- Med-El Corp.
- Date received
- 2020-04-10
- Decision date
- 2020-10-07
- Days to decision
- 180 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Innsbruck
- Statement
- Approval for modification of the approved labeling for the MedEl EAS Cochlear Implant System to reflect the findings of the Post-Approval Study.
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