PMA P000025S029
- Device
- COMBI 40+ COCHLEAR IMPLANT SYSTEM WITH OPUS 2 SPEECH PROCESSOR
- Applicant
- Med-El Corp.
- PMA number
- P000025
- Supplement
- S029
- Product code
- MCM
- Decision date
- 2008-04-08
- Classification
- Implant, Cochlear
- Generic name
- Implant, cochlear
- Approval order statement
- APPROVAL FOR THE OPUS 2 SPEECH PROCESSOR AS AN ADDITIONAL EXTERNAL BEHIND-THE-EAR SPEECH PROCESSOR FOR USE WITH THE COMBI 40+ COCHLEAR IMPLANT SYSTEM.
Current openFDA PMA Record#
- Device
- COMBI 40+ COCHLEAR IMPLANT SYSTEM WITH OPUS 2 SPEECH PROCESSOR
- Applicant
- Med-El Corp.
- PMA number
- P000025
- Supplement
- S029
- Product code
- MCM
- Generic name
- Implant, cochlear
- Decision date
- 2008-04-08
- Decision code
- APPR
- Date received
- 2007-10-25
- Supplement type
- Normal 180 Day Track
- Approval order statement
- APPROVAL FOR THE OPUS 2 SPEECH PROCESSOR AS AN ADDITIONAL EXTERNAL BEHIND-THE-EAR SPEECH PROCESSOR FOR USE WITH THE COMBI 40+ COCHLEAR IMPLANT SYSTEM.