- Device
- Nucleus Hybrid L24 Cochlear Implant System
- Applicant
- Cochlear Americas
- PMA number
- P130016
- Supplement
- S043
- Product code
- PGQ
- Generic name
- Cochlear implant with combined electrical stimulation and acoustic amplification
- Decision date
- 2020-02-21
- Decision code
- APPR
- Date received
- 2020-01-14
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for changes to MR Conditional labeling for CI24REH, CI24RE and CI500 Series Cochlear Implants.