PMA P000025S078
- Device
- COMBI 40+ COCHLEAR IMPLANT SYSTEM
- Applicant
- Med-El Corp.
- PMA number
- P000025
- Supplement
- S078
- Product code
- MCM
- Decision date
- 2014-12-08
- Classification
- Implant, Cochlear
- Generic name
- Implant, cochlear
- Approval order statement
- Approval for the SONNET audio processor, MAESTRO 6.0 software, and RONDO WaterWear accessory.
Current openFDA PMA Record#
- Device
- COMBI 40+ COCHLEAR IMPLANT SYSTEM
- Applicant
- Med-El Corp.
- PMA number
- P000025
- Supplement
- S078
- Product code
- MCM
- Generic name
- Implant, cochlear
- Decision date
- 2014-12-08
- Decision code
- APPR
- Date received
- 2014-06-09
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for the SONNET audio processor, MAESTRO 6.0 software, and RONDO WaterWear accessory.