|
Device | NUCLEUS 22 COCHLEAR IMPLANT SYSTEM/ADULTS |
Generic Name | Implant, cochlear |
Applicant | Cochlear Americas 10350 Park Meadows Drive Lone Tree, CO 80124 |
PMA Number | P840024 |
Supplement Number | S083 |
Date Received | 08/28/2002 |
Decision Date | 09/24/2002 |
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 PROPOSED LABELING CHANGES AS OUTLINED IN ATTACHMENT 3. |