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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-EMINENCE AND CONDY LAR PROSTHESIS SYSTEM
Classification Namejoint, temporomandibular, implant
Generic Namejoint, temporomandibular, implant
Regulation Number872.3940
Applicant
NEXUS CMF, LLC
17301 west colfax avenue
suite 170
golden, CO 80401
PMA NumberP000023
Supplement NumberS010
Date Received05/02/2014
Decision Date05/21/2014
Product Code
LZD[ Registered Establishments with LZD ]
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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