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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.
 
DeviceNUCLEUS HYBRID L24 IMPLANT SYSTEM
Classification Namecochlear implant with combined electrical stimulation and acoustic amplification
Generic Namecochlear implant with combined electrical stimulation and acoustic amplification
Applicant
Cochlear Americas
13059 east peakview avenue
centennial, CO 80111
PMA NumberP130016
Supplement NumberS002
Date Received04/02/2014
Decision Date07/01/2014
Product Code
PGQ[ Registered Establishments with PGQ ]
Advisory Committee Ear Nose & Throat
Supplement Typereal-time process
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for an mr indication at 1. 5 tesla under specific scanning conditions with the magnet surgically removed prior to the mr scan, for the hybrid l24 implant system.
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