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 24 COCHLEAR IMPLANT SYSTEM WITH CONTOUR SOFTIP ELECTRODE |
Generic Name | Implant, cochlear |
Applicant | Cochlear Americas 10350 Park Meadows Drive Lone Tree, CO 80124 |
PMA Number | P970051 |
Supplement Number | S026 |
Date Received | 09/04/2003 |
Decision Date | 09/25/2003 |
Product Code |
MCM |
Advisory Committee |
Ear Nose & Throat |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR DECREASING THE RADIUS OF THE MAGNET OPENING IN THE SILICONE FROM 6 MM TO 5.3 MM. |
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