PMA P970051S141
- Device
- NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
- Applicant
- Cochlear Americas
- PMA number
- P970051
- Supplement
- S141
- Product code
- MCM
- Decision date
- 2016-02-04
- Classification
- Implant, Cochlear
- Generic name
- Implant, cochlear
- Approval order statement
- Introduction of a revised cleaning process for the CI24RE(CA), CI24RE(ST), and CI422 implant electronic assemblies.
Current openFDA PMA Record#
- Device
- NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
- Applicant
- Cochlear Americas
- PMA number
- P970051
- Supplement
- S141
- Product code
- MCM
- Generic name
- Implant, cochlear
- Decision date
- 2016-02-04
- Decision code
- OK30
- Date received
- 2016-01-05
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Introduction of a revised cleaning process for the CI24RE(CA), CI24RE(ST), and CI422 implant electronic assemblies.