PMA P130016S042
- Device
- Nucleus Hybrid L24 Implant System
- Applicant
- Cochlear Americas
- Product code
- PGQ
- Decision date
- 2020-07-28
- Generic name
- Cochlear implant with combined electrical stimulation and acoustic amplification
- Approval order statement
- Approval for PAS Final labeling Extended Follow-up Study.
Current openFDA PMA Record#
- Device
- Nucleus Hybrid L24 Implant System
- Applicant
- Cochlear Americas
- PMA number
- P130016
- Supplement
- S042
- Product code
- PGQ
- Generic name
- Cochlear implant with combined electrical stimulation and acoustic amplification
- Decision date
- 2020-07-28
- Decision code
- APPR
- Date received
- 2020-01-30
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Approval order statement
- Approval for PAS Final labeling Extended Follow-up Study.