PMA P000025S115
- Device
- MedEl EAS System
- Applicant
- Med-El Corp.
- Product code
- MCM
- Decision date
- 2020-10-07
- Generic name
- Implant, cochlear
- Approval order statement
- Approval for modification of the approved labeling for the MedEl EAS Cochlear Implant System to reflect the findings of the Post-Approval Study.
Current openFDA PMA Record#
- Device
- MedEl EAS System
- Applicant
- Med-El Corp.
- PMA number
- P000025
- Supplement
- S115
- Product code
- MCM
- Generic name
- Implant, cochlear
- Decision date
- 2020-10-07
- Decision code
- APPR
- Date received
- 2020-04-10
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Approval order statement
- Approval for modification of the approved labeling for the MedEl EAS Cochlear Implant System to reflect the findings of the Post-Approval Study.