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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 NumberS004
Date Received12/13/2012
Decision Date01/11/2013
Product Code
MJO[ Registered Establishments with MJO ]
Advisory Committee Orthopedic
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Use of a new location for the porous coating process performed at the firm?s supplier.
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