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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.
Classification Nameglenoid fossa prosthesis
Generic Nameglenoid fossa prosthesis
Regulation Number872.3950
17301 west colfax avenue
suite 170
golden, CO 80401
PMA NumberP000035
Supplement NumberS008
Date Received05/03/2012
Decision Date09/06/2012
Product Code
MPI[ Registered Establishments with MPI ]
Advisory Committee Dental
Supplement Type135 review track for 30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for changes in degreasing solvent, cutting/machine lubricants and packaging equipment.