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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 (ADULT) FLEX LEAD ELECTRODE
Generic Namecochlear implant
ApplicantADVANCED BIONICS CORP.
PMA NumberP940022
Supplement NumberS004
Date Received12/23/1997
Decision Date03/17/1998
Advisory Committee Ear Nose & Throat
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval of a modified ics lead electrode, i. E. , the flex lead electrode.
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