|Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.|
|Trade Name||TMJ FOSSA-EMINENCE PROSTHESIS SYSTEM|
|Classification Name||glenoid fossa prosthesis|
|Supplement Type||normal 180 day track no user fee|
|Supplement Reason|| labeling change - other|
|Expedited Review Granted?|| No|
|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.