PMA P200021S014
- Device
- Neuro Cochlear Implant System
- Applicant
- Oticon Medical
- PMA number
- P200021
- Supplement
- S014
- Product code
- MCM
- Decision date
- 2022-06-17
- Generic name
- Implant, cochlear
- Approval order statement
- Improved equipment and manufacturing workflow at the electronic assembly supplier; and (2 modification to the tooling used for feedthrough leak testing.
Current openFDA PMA Record#
- Device
- Neuro Cochlear Implant System
- Applicant
- Oticon Medical
- PMA number
- P200021
- Supplement
- S014
- Product code
- MCM
- Generic name
- Implant, cochlear
- Decision date
- 2022-06-17
- Decision code
- OK30
- Date received
- 2022-05-18
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Improved equipment and manufacturing workflow at the electronic assembly supplier; and (2 modification to the tooling used for feedthrough leak testing.