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 | NUCLEUS COCHLEAR IMPLANT SYSTEM |
Generic Name | Implant, cochlear |
Applicant | Cochlear Americas 10350 Park Meadows Drive Lone Tree, CO 80124 |
PMA Number | P970051 |
Supplement Number | S137 |
Date Received | 11/23/2015 |
Decision Date | 07/08/2016 |
Product Code |
MCM |
Advisory Committee |
Ear Nose & Throat |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement Approval requested for 1) a change in indications to allow MRI of implant recipients at 1.5T with the implant magnet in place for CI512, CI522, CI532, CI422, CI24REH, CI24RE(CA), and CI24RE(ST) provided that a Cochlear-supplied MRI kit is used; 2) a change in indications to allow MRI of implant recipients at 3.0T with the implant magnet removed for CI512, CI522, CI532, CI422, CI24REH, CI24RE(CA), and CI24RE(ST); and 3) consolidation of MRI-related labeling into a single document that provides appropriate instructions for the following Cochlear-manufactured implants: CI512, CI522, CI532, CI422, CI24REH, CI24RE(CA), CI24RE(ST), CI24R(CA), CI24R(CS), CI24R(ST), CI24M, and CI 11+11+2M. |
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