- Device
- Nucleus® Hybrid Cochlear Implant
- Applicant
- Cochlear Americas
- PMA number
- P130016
- Supplement
- S055
- Product code
- PGQ
- Generic name
- Cochlear implant with combined electrical stimulation and acoustic amplification
- Decision date
- 2023-12-13
- Decision code
- OK30
- Date received
- 2023-11-13
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- introduction of new manufacturing processes for making battery subcomponents of the CP1000 and CP1100 sound processors