PMA P200021S005
- Device
- Neuro Cochlear Implant System (“NCIS”)
- Applicant
- Oticon Medical
- PMA number
- P200021
- Supplement
- S005
- Product code
- MCM
- Decision date
- 2021-09-22
- Generic name
- Implant, cochlear
- Approval order statement
- Installation of a laminar flow workbench to improve environmental controls and increase production capacity.
Current openFDA PMA Record#
- Device
- Neuro Cochlear Implant System (“NCIS”)
- Applicant
- Oticon Medical
- PMA number
- P200021
- Supplement
- S005
- Product code
- MCM
- Generic name
- Implant, cochlear
- Decision date
- 2021-09-22
- Decision code
- OK30
- Date received
- 2021-08-23
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Installation of a laminar flow workbench to improve environmental controls and increase production capacity.