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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 NumberS037
Date Received05/10/2004
Decision Date07/23/2004
Product Code
MCM[ Registered Establishments with MCM ]
Advisory Committee Ear Nose & Throat
Supplement Type Special Supplement
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for expansion of the in-process inspection procedure for the hires 90k implant. Namely, the pma supplement proposed to add an additional visual inspection step to ensure weld integrity by using a minimum of 80x magnification to verify the following: 1) complete closure of the weld hold, 2) acceptable weld quality, and 3) absence of foreign material at the weld site.
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