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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.
 
DeviceSECURE -C CERVICAL ARTIFICIAL DISC
Generic NameProsthesis, intervertebral disc
ApplicantGlobus Medical, Inc.
2560 General Armistead Ave.
Audubon, PA 19403
PMA NumberP100003
Supplement NumberS006
Date Received07/01/2015
Decision Date05/17/2016
Product Code MJO 
Advisory Committee Orthopedic
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for clarifying the worst-case temperature rise for the subject device and revising the labeling to adequately reflect those temperature. The Secure-C Cervical Artificial Disc can be now be labeled as MR Compatible.
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