PMA P000025S041
- Device
- COMBI 40+ COCHLEAR IMPLANT SYSTEM
- Applicant
- Med-El Corp.
- PMA number
- P000025
- Supplement
- S041
- Product code
- MCM
- Decision date
- 2009-09-03
- Classification
- Implant, Cochlear
- Generic name
- Implant, cochlear
- Approval order statement
- APPROVAL FOR THE ADDITION OF A SECOND SOURCE SUPPLIER FOR THE FEEDTHROUGH ASSEMBLY.
Current openFDA PMA Record#
- Device
- COMBI 40+ COCHLEAR IMPLANT SYSTEM
- Applicant
- Med-El Corp.
- PMA number
- P000025
- Supplement
- S041
- Product code
- MCM
- Generic name
- Implant, cochlear
- Decision date
- 2009-09-03
- Decision code
- APPR
- Date received
- 2009-04-22
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR THE ADDITION OF A SECOND SOURCE SUPPLIER FOR THE FEEDTHROUGH ASSEMBLY.