PMA P130016S022
- Device
- NUCLEUS HYBRID L24 IMPLANT SYSTEM
- Applicant
- Cochlear Americas
- PMA number
- P130016
- Supplement
- S022
- 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
- Approval order should be issued for the new CP1000 N7 cochlear implant sound processor.
Current openFDA PMA Record#
- Device
- NUCLEUS HYBRID L24 IMPLANT SYSTEM
- Applicant
- Cochlear Americas
- PMA number
- P130016
- Supplement
- S022
- Product code
- PGQ
- Generic name
- Cochlear implant with combined electrical stimulation and acoustic amplification
- Decision date
- 2017-06-13
- Decision code
- APPR
- Date received
- 2016-10-12
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval order should be issued for the new CP1000 N7 cochlear implant sound processor.