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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
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 NumberS008
Date Received05/03/2012
Decision Date09/06/2012
Product Code
MPI[ Registered Establishments with MPI ]
Advisory Committee Dental
Supplement Type135 review track for 30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR CHANGES IN DEGREASING SOLVENT, CUTTING/MACHINE LUBRICANTS AND PACKAGING EQUIPMENT.
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