PMA P000025S081
- Device
- MED-EL COCHLEAR IMPLANT SYSTEM
- Applicant
- Med-El Corp.
- PMA number
- P000025
- Supplement
- S081
- Product code
- MCM
- Decision date
- 2015-03-11
- Classification
- Implant, Cochlear
- Generic name
- Implant, cochlear
- Approval order statement
- APPROVAL FOR THE DL-COIL, AN EXTERNAL AUDIO PROCESSOR COIL FOR USE WITH THE MED-EL COCHLEAR IMPLANT, AS PART OF THE COMBI 40+ COCHLEAR IMPLANT SYSTEM.
Current openFDA PMA Record#
- Device
- MED-EL COCHLEAR IMPLANT SYSTEM
- Applicant
- Med-El Corp.
- PMA number
- P000025
- Supplement
- S081
- Product code
- MCM
- Generic name
- Implant, cochlear
- Decision date
- 2015-03-11
- Decision code
- APPR
- Date received
- 2014-12-11
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR THE DL-COIL, AN EXTERNAL AUDIO PROCESSOR COIL FOR USE WITH THE MED-EL COCHLEAR IMPLANT, AS PART OF THE COMBI 40+ COCHLEAR IMPLANT SYSTEM.