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 NUCLEUS 24 CONTOUR ADVANCE/SOFTIP II ELECTRODE AND INSERTION TOOL |
Generic Name | Implant, cochlear |
Applicant | Cochlear Americas 10350 Park Meadows Drive Lone Tree, CO 80124 |
PMA Number | P970051 |
Supplement Number | S027 |
Date Received | 10/06/2003 |
Decision Date | 05/18/2004 |
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 |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR AN ELECTRODE INSERTION TOOL TO FACILITATE PLACEMENT OF THE ELECTRODE INTO THE COCHLEA AS WELL AS MINOR MODIFICATIONS TO THE SOFTIP ELECTRODE TO OPTIMIZE ITS INTERACTION WITH THE INSERTION TOOL. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME INSERTION TOOL FOR THE NUCLEUS 24 CONTOUR ADVANCE/SOFTIP ELECTRODE II. |
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