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 |
Generic Name | Implant, cochlear |
Applicant | ADVANCED BIONICS 28515 WESTINGHOUSE PLACE VALENCIA, CA 91355 |
PMA Number | P960058 |
Supplement Number | S131 |
Date Received | 09/07/2018 |
Decision Date | 08/30/2019 |
Product Code |
MCM |
Advisory Committee |
Ear Nose & Throat |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval of the HiRes Fidelity 120 and HiRes Optima sound processing strategies for adults and pediatric patients 12 months and older.Approval of the ClearVoice and Front-End Processing features of StereoZoom, UltraZoom, SoundRelax, WindBlock, and EchoBlock for pediatric population 6 years and older. |
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