PMA P970051S204
- Device
- Nucleus 24 Cochlear Implant System
- Applicant
- Cochlear Americas
- PMA number
- P970051
- Supplement
- S204
- Product code
- MCM
- Decision date
- 2021-03-26
- Generic name
- Implant, cochlear
- Approval order statement
- Add an automated magnet detector to verify the presence of the magnet before the implant is released.
Current openFDA PMA Record#
- Device
- Nucleus 24 Cochlear Implant System
- Applicant
- Cochlear Americas
- PMA number
- P970051
- Supplement
- S204
- Product code
- MCM
- Generic name
- Implant, cochlear
- Decision date
- 2021-03-26
- Decision code
- OK30
- Date received
- 2021-02-24
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Add an automated magnet detector to verify the presence of the magnet before the implant is released.