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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 NameNUCLEUS 24 CONTOUR COCHLEAR IMPLANT SYSTEM
Classification Nameimplant, cochlear
Generic Namenucleus 24 cochlear implant system
ApplicantCOCHLEAR CORP.
PMA NumberP970051
Supplement NumberS013
Date Received12/29/2000
Decision Date03/02/2001
Product Code
MCM[ Registered Establishments with MCM ]
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 for a new headset, hs9, which consists of a lapel microphone, a transmitting coil and a cable designed to connect directly to the sprint speech processor.
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