|
Device | NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM |
Generic Name | Implant, cochlear |
Applicant | Cochlear Americas 10350 Park Meadows Drive Lone Tree, CO 80124 |
PMA Number | P840024 |
Supplement Number | S074 |
Date Received | 02/09/1998 |
Decision Date | 03/06/1998 |
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 changes in the package insert labeling to 1) include the indication for children age 18 months to 17 years and 2) to modify the adverse effects section. |