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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 may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameTMJ FOSSA-EMINENCE/CONDYLAR PROSTHESES
Classification Namejoint, temporomandibular, implant
Regulation Number872.3940
ApplicantNEXUS CMF, LLC
PMA NumberP000023
Date Received06/20/2000
Decision Date01/05/2001
Product Code
LZD[ Registered Establishments with LZD ]
Docket Number 01M-0255
Notice Date 06/11/2001
Advisory Committee Dental
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
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 Order Approval Order
Supplements: S001 S002 S003 S004 S006 S007 S008 
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