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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.
 
DeviceTMJ FOSSA-EMIENCE PROSTHESIS SYSTEM
Classification Nameglenoid fossa prosthesis
Generic Nameglenoid fossa prosthesis
Regulation Number872.3950
Applicant
NEXUS CMF, LLC
17301 west colfax avenue
suite 170
golden, CO 80401
PMA NumberP000035
Supplement NumberS010
Date Received05/02/2014
Decision Date05/21/2014
Product Code
MPI[ Registered Establishments with MPI ]
Advisory Committee Dental
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Add water quality standards.
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