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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 NumberS001
Date Received05/18/2010
Decision Date03/09/2012
Product Code
MJO[ Registered Establishments with MJO ]
Advisory Committee Orthopedic
Supplement Typenormal 180 day track
Supplement Reason labeling change - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a modified surgical technique, new instrumentation, and modified labeling to include information on mri compatibility of the implanted device.
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