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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 NumberS008
Date Received05/03/2012
Decision Date09/06/2012
Product Code 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 ProductNo
Approval Order Statement  
APPROVAL FOR CHANGES IN DEGREASING SOLVENT, CUTTING/MACHINE LUBRICANTS AND PACKAGING EQUIPMENT.
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