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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
Classification Nameimplant, cochlear
Generic Namecochlear implant (pediatric)
ApplicantADVANCED BIONICS CORP.
PMA NumberP960058
Supplement NumberS038
Date Received07/28/2004
Decision Date08/24/2004
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 an interim design change for the auria powerpak accessory to the hiresolution bionic ear system. Specifically, you propose the addition of an insulating washer to the auria powerpak assembly while you develop a final design solution for the recently discovered safety issue associated with this device. We note that you agree to design, test, manufacture, and distribute the revised auria powerpak model with the final design solution within six months of the date of this letter. We further note that you agree to submit a supplement to fda for the proposed final design once the design and test activities have been complete and will not distribute the revised auria powerpak without fda approval.
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