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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 NameCII BIONIC CAR SYSTEM, HIRES AURIA PROCESSOR AND ACCESSORIES
Classification Nameimplant, cochlear
Generic Namecochlear implant (pediatric)
ApplicantADVANCED BIONICS CORP.
PMA NumberP960058
Supplement NumberS031
Date Received05/23/2003
Decision Date06/06/2003
Product Code
MCM[ Registered Establishments with MCM ]
Advisory Committee Ear Nose & Throat
Supplement Typereal-time process
Supplement Reason design change - minor
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for changes to the following parts of the behind-the-ear (bte) sound processor: 1) the toggle switch, 2) the bte battery, 3) the accessories available with the current bte, 4) the new accessory items, 5) the auria headpiece, and 6) the esd warning in the package insert.
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