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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 (HIRES 90K)
Classification Nameimplant, cochlear
Generic Namecochlear implant (pediatric)
ApplicantADVANCED BIONICS CORP.
PMA NumberP960058
Supplement NumberS030
Date Received03/18/2003
Decision Date07/07/2003
Product Code
MCM[ Registered Establishments with MCM ]
Advisory Committee Ear Nose & Throat
Supplement Typenormal 180 day track
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Recalls CDRH Recalls
Approval Order Statement 
Approval for the repackaged ics (implantable cochlear stimulator), referred to as hires 90k, and its associated surgical tools. The device, as modified, will be marketed under the trade name hiresolution bionic ear system and is indicated for adults and the pediatric population aged 12-months through 17 years, 11-months of age.
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