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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 NameJoint, temporomandibular, implant
Regulation Number872.3940
ApplicantNEXUS CMF, LLC
17301 WEST COLFAX AVENUE
SUITE 170
GOLDEN, CO 80401
PMA NumberP000023
Supplement NumberS003
Date Received06/20/2002
Decision Date01/22/2004
Product Code LZD 
Advisory Committee Dental
Supplement TypeNormal 180 Day Track
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR A NEW MANUFACTURING SITE FOR THE CRYSTALCLEAR ANATOMICAL MODEL. THE SITE IS LOCATED AT TMJ IMPLANTS, INC., GOLDEN, COLORADO.
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