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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/CONDYLAR PROSTHESIS SYSTEM AND TMJ FOSSA-EMINENCE PROSTHESIS
Generic Nameglenoid fossa prosthesis
Regulation Number872.3950
ApplicantNEXUS CMF, LLC
17301 west colfax avenue
suite 170
golden, CO 80401
PMA NumberP000035
Supplement NumberS004
Date Received12/26/2002
Decision Date10/14/2003
Product Code MPI 
Advisory Committee Dental
Supplement Typenormal 180 day track
Supplement Reason other report
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE PACKAGING/SHELF LIFE TESTING PROTOCOL TO EXTEND THE SHELF LIFE BEYOND 6 MONTHS.
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