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 | HIRESOLUTION BIONIC EAR SYSTEM WITH NAIDA CI Q70 SOUND PROCESSOR |
Generic Name | Implant, cochlear |
Applicant | ADVANCED BIONICS 28515 WESTINGHOUSE PLACE VALENCIA, CA 91355 |
PMA Number | P960058 |
Supplement Number | S102 |
Date Received | 02/04/2013 |
Decision Date | 08/19/2013 |
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 |
Approval Order Statement APPROVAL FOR THE NAIDA CI Q70 SOUND PROCESSOR, A SMALLER BEHIND THE EAR (BTE) SOUND PROCESSOR THAT HAS WIRELESS CONNECTIVITY. THE SUPPLEMENT ALSO INCLUDES A COMPLEMENTARY SET OF ACCESSORIES, A NEW CLINICIANS PROGRAMMING INTERFACE, AND A NEW VERSION OF THE SOUNDWAVE FITTING SOFTWARE. |
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