PMA P130016S027
- Device
- Nucleus Hybrid Cochlear Implant System
- Applicant
- Cochlear Americas
- PMA number
- P130016
- Supplement
- S027
- Product code
- PGQ
- Decision date
- 2017-06-13
- Classification
- Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification
- Generic name
- Cochlear implant with combined electrical stimulation and acoustic amplification
- Approval order statement
- Introduction of the new CBO Sprint Cleanroom at the Cochlear Brisbane Operations (CBO) manufacturing site.
Current openFDA PMA Record#
- Device
- Nucleus Hybrid Cochlear Implant System
- Applicant
- Cochlear Americas
- PMA number
- P130016
- Supplement
- S027
- Product code
- PGQ
- Generic name
- Cochlear implant with combined electrical stimulation and acoustic amplification
- Decision date
- 2017-06-13
- Decision code
- OK30
- Date received
- 2017-05-16
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Introduction of the new CBO Sprint Cleanroom at the Cochlear Brisbane Operations (CBO) manufacturing site.