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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 NumberS006
Date Received05/11/2011
Decision Date01/31/2012
Product Code MPI 
Advisory Committee Dental
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR LABELING CHANGES TO UPDATE THE OWNER AND COMPANY NAME, MANUFACTURING SUITE, STANDARDIZATION OF THE PRODUCT NAMES, AND ADVERSE EVENTS SECTION RELATED TO COMPLETION OF THE POST-APPROVAL STUDY.
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