PMA P000025S056
- Device
- MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM
- Applicant
- Med-El Corp.
- PMA number
- P000025
- Supplement
- S056
- Product code
- MCM
- Decision date
- 2011-09-23
- Classification
- Implant, Cochlear
- Generic name
- Implant, cochlear
- Approval order statement
- CHANGE IN EQUIPMENT USED FOR THE PRODUCTION OF THE ELECTRODE WIRES OF ALL COCHLEAR IMPLANTS.
Current openFDA PMA Record#
- Device
- MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM
- Applicant
- Med-El Corp.
- PMA number
- P000025
- Supplement
- S056
- Product code
- MCM
- Generic name
- Implant, cochlear
- Decision date
- 2011-09-23
- Decision code
- OK30
- Date received
- 2011-08-29
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE IN EQUIPMENT USED FOR THE PRODUCTION OF THE ELECTRODE WIRES OF ALL COCHLEAR IMPLANTS.