PMA P000025S111
- Device
- MAESTRO System Software 8.0
- Applicant
- Med-El Corp.
- Product code
- MCM
- Decision date
- 2019-09-27
- Generic name
- Implant, cochlear
- Approval order statement
- Approval for MAESTRO 8.0 fitting software.
Current openFDA PMA Record#
- Device
- MAESTRO System Software 8.0
- Applicant
- Med-El Corp.
- PMA number
- P000025
- Supplement
- S111
- Product code
- MCM
- Generic name
- Implant, cochlear
- Decision date
- 2019-09-27
- Decision code
- APPR
- Date received
- 2019-04-01
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for MAESTRO 8.0 fitting software.