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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.
 
DeviceTMJ FOSSA-EMINENCE PROSTHESIS SYSTEM
Generic Nameglenoid fossa prosthesis
Regulation Number872.3950
ApplicantNEXUS CMF, LLC
17301 west colfax avenue
suite 170
golden, CO 80401
PMA NumberP000035
Supplement NumberS011
Date Received01/16/2015
Decision Date02/13/2015
Product Code MPI 
Advisory Committee Dental
Supplement Type30-day notice
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
CHANGES IN TWO CLEANING PROCESSES.
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