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 THE NAIDA CI AQUACASE |
Generic Name | Implant, cochlear |
Applicant | ADVANCED BIONICS 28515 WESTINGHOUSE PLACE VALENCIA, CA 91355 |
PMA Number | P960058 |
Supplement Number | S106 |
Date Received | 12/13/2013 |
Decision Date | 09/10/2014 |
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 AQUACASE FOR USE WITH THE NAIDA CI Q70 SOUND PROCESSOR. THE NAIDA CI AQUACASE IS AN ACCESSORY TO THE HIRESOLUTION BIONIC EAR SYSTEM. |
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