Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | COCHLEAR NUCLEUS 5 COCHLEAR IMPLANT SYSTEM |
Generic Name | Implant, cochlear |
Applicant | Cochlear Americas 10350 Park Meadows Drive Lone Tree, CO 80124 |
PMA Number | P970051 |
Supplement Number | S068 |
Date Received | 03/10/2011 |
Decision Date | 04/07/2011 |
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 |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR ADDITIONAL LABELING FOR THE CI500 SERIES COCHLEAR IMPLANT. |
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