|
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 | S057 |
Date Received | 10/13/2009 |
Decision Date | 11/12/2009 |
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 ADDITIONAL LABELING TO RECIPIENTS RECEIVING PRE-PROGRAMMED REPAIRED/REPLACED SOUND PROCESSORS. |