PMA P000025S027
- Device
- MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM
- Applicant
- Med-El Corp.
- PMA number
- P000025
- Supplement
- S027
- Product code
- MCM
- Decision date
- 2007-09-25
- Classification
- Implant, Cochlear
- Generic name
- Implant, cochlear
- Approval order statement
- APPROVAL FOR CHANGES TO THE MICROPHONE TEST DEVICE (MTD) USERS MANUAL.
Current openFDA PMA Record#
- Device
- MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM
- Applicant
- Med-El Corp.
- PMA number
- P000025
- Supplement
- S027
- Product code
- MCM
- Generic name
- Implant, cochlear
- Decision date
- 2007-09-25
- Decision code
- APPR
- Date received
- 2007-08-27
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR CHANGES TO THE MICROPHONE TEST DEVICE (MTD) USERS MANUAL.