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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceBRYAN CERVICAL DISC
Classification Nameprosthesis, intervertebral disc
Generic Nameprosthesis, intervertebral disc
Applicant
Medtronic Sofamor Danek USA, Inc.
1800 pyramid place
memphis, TN 38132
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 change design/components/specifications/material
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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