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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.
 
DeviceNUCLEUS 24 COCHLEAR IMPLANT SYSTEM
Generic NameImplant, cochlear
ApplicantCochlear Americas
10350 Park Meadows Drive
Lone Tree, CO 80124
PMA NumberP970051
Supplement NumberS019
Date Received10/23/2001
Decision Date03/21/2002
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 ProductNo
Approval Order Statement  
APPROVAL FOR THE SP-10 BEHIND-THE-EAR SPEECH PROCESSOR WITH ACE, CIS AND SPEAK SPEECH CODING STRATEGIES. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ESPRIT3G AND IS INTENDED TO BE USED WITH THE CI24M, CI24R(ST) AND CI24R(CS) COCHLEAR IMPLANTS.
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