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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 NameBRYAN CERVICAL DISC
Classification Nameprosthesis, intervertebral disc
ApplicantMEDTRONIC SOFAMOR DANEK USA, INC.
PMA NumberP060023
Supplement NumberS002
Date Received04/15/2011
Decision Date09/13/2012
Product Code
MJO[ Registered Establishments with MJO ]
Advisory Committee Orthopedic
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 a change to the injection molding process.
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