PMA P000025S101
- Device
- MED-EL Cochlear Implant System
- Applicant
- Med-El Corp.
- PMA number
- P000025
- Supplement
- S101
- Product code
- MCM
- Decision date
- 2018-07-25
- Classification
- Implant, Cochlear
- Generic name
- Implant, cochlear
- Approval order statement
- Removal of the AETA (Automated Electrode Test Application) as a mandatory test to be performed on all standard Cl electrodes.
Current openFDA PMA Record#
- Device
- MED-EL Cochlear Implant System
- Applicant
- Med-El Corp.
- PMA number
- P000025
- Supplement
- S101
- Product code
- MCM
- Generic name
- Implant, cochlear
- Decision date
- 2018-07-25
- Decision code
- OK30
- Date received
- 2018-06-25
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Removal of the AETA (Automated Electrode Test Application) as a mandatory test to be performed on all standard Cl electrodes.