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 | S078 |
Date Received | 06/24/2011 |
Decision Date | 07/21/2011 |
Product Code |
MCM |
Advisory Committee |
Ear Nose & Throat |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement CHANGES TO: 1) THE TEST SYSTEMS (ACOUSTIC AND WIRELESS) TO UPDATE TEST EQUIPMENT AND FIRMWARE; 2) ADDITIONAL TESTS FOR THE DIGITAL SOUND PROCESSING MEMORY; 3) MODIFICATION TO TEST LIMITS; AND 4) MINOR CHANGES TO THE SYSTEM USER INTERFACE AND TEST REPORT FORMAT. |
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