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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameHIRESOLUTION BIONIC EAR SYSTEM WITH NAIDA CI Q70 SOUND PROCESSOR
Classification Nameimplant, cochlear
Generic Namecochlear implant
ApplicantADVANCED BIONICS LLC
PMA NumberP960058
Supplement NumberS102
Date Received02/11/2013
Decision Date08/19/2013
Product Code
MCM[ Registered Establishments with MCM ]
Advisory Committee Ear Nose & Throat
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
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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