PMA P130016S036
- Device
- Nucleus Hybrid Cochlear Implant System
- Applicant
- Cochlear Americas
- PMA number
- P130016
- Supplement
- S036
- Product code
- PGQ
- Decision date
- 2019-06-05
- 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 new accessories and modifications to the firmware and software of the Nucleus 7 system, as well as a research tool named the Cochlear Research Platform.
Current openFDA PMA Record#
- Device
- Nucleus Hybrid Cochlear Implant System
- Applicant
- Cochlear Americas
- PMA number
- P130016
- Supplement
- S036
- Product code
- PGQ
- Generic name
- Cochlear implant with combined electrical stimulation and acoustic amplification
- Decision date
- 2019-06-05
- Decision code
- APPR
- Date received
- 2018-11-01
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval order should be issued for new accessories and modifications to the firmware and software of the Nucleus 7 system, as well as a research tool named the Cochlear Research Platform.