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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.
 
DevicePLATINUM SOUND PROCESSOR (COCHLEAR IMPLANT)
Generic Nameimplant, cochlear
Applicant
ADVANCED BIONICS CORP.
12740 san fernando rd.
sylmar, CA 91342
PMA NumberP940022
Supplement NumberS013
Date Received11/12/1999
Decision Date02/02/2000
Product Code MCM 
Advisory Committee Ear Nose & Throat
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Size reduction in the speech processor known as the Platinum Sound Processor.
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