|
Device | Nucleus Hybrid L24 Cochlear Implant System |
Generic Name | Cochlear implant with combined electrical stimulation and acoustic amplification |
Applicant | Cochlear Americas 10350 Park Meadows Drive Centennial, CO 80124 |
PMA Number | P130016 |
Supplement Number | S043 |
Date Received | 01/14/2020 |
Decision Date | 02/21/2020 |
Product Code |
PGQ |
Advisory Committee |
Ear Nose & Throat |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for changes to MR Conditional labeling for CI24REH, CI24RE and CI500 Series Cochlear Implants. |