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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceTMJ FOSSA-EMINENCE/CONDYLAR PROSTHESES
Generic NameJoint, temporomandibular, implant
Regulation Number872.3940
ApplicantNEXUS CMF, LLC
17301 WEST COLFAX AVENUE
SUITE 170
GOLDEN, CO 80401
PMA NumberP000023
Date Received06/20/2000
Decision Date01/05/2001
Product Code LZD 
Docket Number 01M-0255
Notice Date 06/11/2001
Advisory Committee Dental
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE TMJ FOSSA-EMINENCE/CONDYLAR PROSTHESIS SYSTEM. THE DEVICE IS INDICATED FOR RECONSTRUCTION OF THE TEMPOROMANDIBULAR JOINT. PATIENTS SHOULD BE CONSIDERED IF THEY HAVE ONE OR MORE OF THE FOLLOWING CONDITIONS: 1) INFLAMMATORY ARTHRITIS INVOLVING THE TEMPOROMANDIBULAR JOINT NOT RESPONSIVE TO OTHER MODALITIES OF TREATMENT 2) RECURRENT FIBROUS AND/OR BONY ANKYLOSIS NOT RESPONSIVE TO OTHER MODALITIES OF TREATMENT 3) FAILED TISSUE GRAFT 4) FAILED ALLOPLASTIC JOINT RECONSTRUCTION 5) LOSS OF VERTICAL MANDIBULAR HEIGHT AND/OR OCCLUSAL RELATIONSHIP DUE TO BONE RESORPTION, TRAUMA, DEVELOPMENTAL RELATIONSHIP DUE TO BONE RESORPTION, TRAUMA, DEVELOPMENTAL ABNORMALITY, OR PATHOLOGIC LESION.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
Supplements:  S001 S002 S003 S004 S006 S007 S008 S009 S010 S011 
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