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. |
|
Device | HIRESOLUTION BIONIC EAR SYSTEM |
Generic Name | Implant, cochlear |
Applicant | ADVANCED BIONICS 28515 WESTINGHOUSE PLACE VALENCIA, CA 91355 |
PMA Number | P960058 |
Supplement Number | S114 |
Date Received | 01/02/2015 |
Decision Date | 08/14/2015 |
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 EXPANDING THE NAÍDA CI SOUND PROCESSOR FAMILY, WHICH AREEXTERNAL COMPONENTS OF THE HIRESOLUTION BIONIC EAR SYSTEM, BY ADDING TWO NEW SOUND PROCESSORS (CI Q90 AND CI Q30), NEW VERSIONS OF THE POWERCEL BATTERY, AND A NEW VERSION OF THE SOUNDWAVE PROFESSIONAL SUITE FITTING SOFTWARE. |
|
|