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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 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 NameTMJ FOSSA-EMINENCE AND CONDYLAR PROSTHESIS SYSTEM
Classification Namejoint, temporomandibular, implant
Regulation Number872.3940
ApplicantTMJ MEDICAL
PMA NumberP000023
Supplement NumberS008
Date Received05/04/2012
Decision Date09/06/2012
Product Code
LZD[ Registered Establishments with LZD ]
Advisory Committee Dental
Supplement Type135 review track for 30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for changes in degreasing solvent, cutting/machine lubricants and packaging equipment.
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