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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(TM) MULTI-STRATEGY COCHLEAR IMPLANT VERSION 1.2
Generic Namecochlear implant
ApplicantADVANCED BIONICS CORP.
PMA NumberP940022
Supplement NumberS001
Date Received04/05/1996
Decision Date08/02/1996
Advisory Committee Ear Nose & Throat
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to modify the design of the clarion multi-strategy cochlear impaltn from the original 1. 0 version to the miniaturized 1. 2 version.
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