PMA P130016S030
- Device
- Nucleus Hybrid Implant System
- Applicant
- Cochlear Americas
- PMA number
- P130016
- Supplement
- S030
- Product code
- PGQ
- Decision date
- 2017-09-20
- 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 for an update to the Cochlear Integrity Test System version 1.4 to version 1.5. The update to version 1.5 from 1.4 is a minor software change that includes 1) the addition of a dropdown box for Cochlear employees to select the CI532 with Slim Modiolar Electrode from the suite of compatible implants; and 2) a revision to the stimulation safety limits.
Current openFDA PMA Record#
- Device
- Nucleus Hybrid Implant System
- Applicant
- Cochlear Americas
- PMA number
- P130016
- Supplement
- S030
- Product code
- PGQ
- Generic name
- Cochlear implant with combined electrical stimulation and acoustic amplification
- Decision date
- 2017-09-20
- Decision code
- APPR
- Date received
- 2017-06-21
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for an update to the Cochlear Integrity Test System version 1.4 to version 1.5. The update to version 1.5 from 1.4 is a minor software change that includes 1) the addition of a dropdown box for Cochlear employees to select the CI532 with Slim Modiolar Electrode from the suite of compatible implants; and 2) a revision to the stimulation safety limits.