PMA P200021S004
- Device
- Neuro Cochlear Implant System
- Applicant
- Oticon Medical
- PMA number
- P200021
- Supplement
- S004
- Product code
- MCM
- Decision date
- 2021-09-10
- Generic name
- Implant, cochlear
- Approval order statement
- Modifications to the acceptance criteria for the chemical composition of the feedthrough sandblasting material and to the leak test method for the magnet casing.
Current openFDA PMA Record#
- Device
- Neuro Cochlear Implant System
- Applicant
- Oticon Medical
- PMA number
- P200021
- Supplement
- S004
- Product code
- MCM
- Generic name
- Implant, cochlear
- Decision date
- 2021-09-10
- Decision code
- OK30
- Date received
- 2021-08-11
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Modifications to the acceptance criteria for the chemical composition of the feedthrough sandblasting material and to the leak test method for the magnet casing.