PMA P000025S093
- Device
- COMBI 40+ Cochlear Implant System
- Applicant
- Med-El Corp.
- PMA number
- P000025
- Supplement
- S093
- Product code
- MCM
- Decision date
- 2017-03-29
- Classification
- Implant, Cochlear
- Generic name
- Implant, cochlear
- Approval order statement
- Change in the test method of the feedthrough components of the cochlear implants.
Current openFDA PMA Record#
- Device
- COMBI 40+ Cochlear Implant System
- Applicant
- Med-El Corp.
- PMA number
- P000025
- Supplement
- S093
- Product code
- MCM
- Generic name
- Implant, cochlear
- Decision date
- 2017-03-29
- Decision code
- OK30
- Date received
- 2017-02-27
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change in the test method of the feedthrough components of the cochlear implants.