|
Device | Nucleus 22 Cochlear Implant System |
Generic Name | Implant, cochlear |
Applicant | Cochlear Americas 10350 Park Meadows Drive Lone Tree, CO 80124 |
PMA Number | P890027 |
Supplement Number | S058 |
Date Received | 02/09/2017 |
Decision Date | 12/14/2017 |
Product Code |
MCM |
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 a change in clinical guidance for programming Nucleus cochlear implant recipients in bipolar mode. |