PMA P970051S173
- Device
- Nucleus Cochlear Implant System
- Applicant
- Cochlear Americas
- PMA number
- P970051
- Supplement
- S173
- Product code
- MCM
- Decision date
- 2018-06-13
- Classification
- Implant, Cochlear
- Generic name
- Implant, cochlear
- Approval order statement
- Approval for the modifications to the firmware and software of the Nucleus 7 system as well as a modification to the Custom Sound EP used with the Nucleus 6 system.
Current openFDA PMA Record#
- Device
- Nucleus Cochlear Implant System
- Applicant
- Cochlear Americas
- PMA number
- P970051
- Supplement
- S173
- Product code
- MCM
- Generic name
- Implant, cochlear
- Decision date
- 2018-06-13
- Decision code
- APPR
- Date received
- 2017-11-13
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for the modifications to the firmware and software of the Nucleus 7 system as well as a modification to the Custom Sound EP used with the Nucleus 6 system.