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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceCLARION MULTI-STRATEGY COCHLEAR IMPLANT(ADULT)
Generic Nameimplant, cochlear
Applicant
ADVANCED BIONICS CORP.
12740 san fernando rd.
sylmar, CA 91342
PMA NumberP940022
Supplement NumberS010
Date Received02/04/1999
Decision Date03/22/1999
Product Code MCM 
Advisory Committee Ear Nose & Throat
Supplement Typenormal 180 day track
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for an alternate sterilization site located at Griffith Micro Science, Inc., 5725 West Harold Gatty Drive, Salt Lake City, Utah 84116.
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