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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 NameCLARION CII BIONIC EAR SYSTEM (PEDIATRIC)
Classification Nameimplant, cochlear
Generic Namecochlear implant (pediatric)
ApplicantADVANCED BIONICS CORP.
PMA NumberP960058
Supplement NumberS026
Date Received10/25/2002
Decision Date11/01/2002
Product Code
MCM[ Registered Establishments with MCM ]
Advisory Committee Ear Nose & Throat
Supplement Typereal-time process
Supplement Reason postapproval protocol or modification to a protocol
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the following changes to the postmarket study protocol: 1) use of only the pb-k test to determine candidacy in children 4 years through 17 years of age at time of implant. 2) substitution of the pb-k test for the esp test as an outcome measure. 3) division of the youngest age group into two groups. 4) additional inclusion/exclusion criteria for adults and children.
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