PMA P200021S006
- Device
- Neuro Cochlear Implant System
- Applicant
- Oticon Medical
- PMA number
- P200021
- Supplement
- S006
- Product code
- MCM
- Decision date
- 2021-10-26
- Generic name
- Implant, cochlear
- Approval order statement
- Oticon Medical LLC as the initial importer with responsibility for certain manufacturing activities
Current openFDA PMA Record#
- Device
- Neuro Cochlear Implant System
- Applicant
- Oticon Medical
- PMA number
- P200021
- Supplement
- S006
- Product code
- MCM
- Generic name
- Implant, cochlear
- Decision date
- 2021-10-26
- Decision code
- OK30
- Date received
- 2021-09-27
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Oticon Medical LLC as the initial importer with responsibility for certain manufacturing activities