|
Device | NUCLEUS 24 COCHLEAR IMPLANT SYSTEM WITH CONTOUR ADVANCE |
Generic Name | Implant, cochlear |
Applicant | Cochlear Americas 10350 Park Meadows Drive Lone Tree, CO 80124 |
PMA Number | P970051 |
Supplement Number | S025 |
Date Received | 08/13/2003 |
Decision Date | 11/07/2003 |
Product Code |
MCM |
Advisory Committee |
Ear Nose & Throat |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL OF A MARKETING NAME CHANGE FROM NUCLEUS 24 COCHLEAR IMPLANT SYSTEM WITH CONTOUR SOFTIP ELECTRODE TO NUCLEUS 24 CONTOUR ADVANCE. |