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.
 
DeviceNUCLEUS 24 COCHLEAR IMPLANT SYSTEM
Generic NameImplant, cochlear
ApplicantCochlear Americas
10350 Park Meadows Drive
Lone Tree, CO 80124
PMA NumberP970051
Supplement NumberS096
Date Received08/27/2012
Decision Date08/02/2013
Product Code MCM 
Advisory Committee Ear Nose & Throat
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE NUCLEUS 6 COCHLEAR IMPLANT SYSTEM, A NEW SUITE OF EXTERNAL ACCESSORIES AND PROGRAMMING SOFTWARE TO BE USED WITH THE NUCLEUS 24 COCHLEAR IMPLANT, INCLUDING EXTERNAL SOUND PROCESSORS (CP910 AND CP920), USER REMOTE ASSISTANTS (CR210 AND CR230), INTRAOPERATIVE REMOTE ASSISTANT (CR220), AND PROGRAMMING SOFTWARE (CUSTOM SOUND SUITE 4 COMPRISED OF CUSTOM SOUND 4 AND CUSTOM SOUND EP 4).