PMA P000025S051
- Device
- MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM
- Applicant
- Med-El Corp.
- PMA number
- P000025
- Supplement
- S051
- Product code
- MCM
- Decision date
- 2011-08-26
- Classification
- Implant, Cochlear
- Generic name
- Implant, cochlear
- Approval order statement
- APPROVAL FOR SEVERAL MANUFACTURING PROCESS CHANGES FOR THE COCHLEAR IMPLANTS.
Current openFDA PMA Record#
- Device
- MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM
- Applicant
- Med-El Corp.
- PMA number
- P000025
- Supplement
- S051
- Product code
- MCM
- Generic name
- Implant, cochlear
- Decision date
- 2011-08-26
- Decision code
- APPR
- Date received
- 2011-04-25
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR SEVERAL MANUFACTURING PROCESS CHANGES FOR THE COCHLEAR IMPLANTS.