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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.
Classification Nameglenoid fossa prosthesis
Regulation Number872.3950
PMA NumberP000035
Date Received06/20/2000
Decision Date02/27/2001
Product Code
MPI[ Registered Establishments with MPI ]
Docket Number 01M-0210
Notice Date 05/14/2001
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 prosthesis(tm). The device is indicated for use in treatment of severe temporomandibular joint disease due to: 1) inflammatory arthritis involving the temporomandibular joint not responsive to other modalities of treatment, 2) recurrent fibrosis and/or bony ankylosis not responsive to other modalities of treatment, 3) failed tissue graft, 4) failed alloplastic joint reconstruction, 5) internal derangement confirmed to be pathological in origin by both clinical observation and radiographic findings, where the patient has moderate to severe pain and/or disabling dysfunction and has not responded to less invasive conventional therapy.
Approval Order Approval Order
Supplements: S001 S002 S003 S004 S006 S007 S008 S009 S010