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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.
 
Deviceprodisc C Total Disc Replacement
Generic NameProsthesis, intervertebral disc
ApplicantCentinel Spine, LLC
900 Airport Rd., Suite 3b
West Chester, PA 19380
PMA NumberP070001
Supplement NumberS017
Date Received12/04/2018
Decision Date05/31/2019
Product Code MJO 
Advisory Committee Orthopedic
Clinical TrialsNCT00291018
Supplement TypeNormal 180 Day Track No User Fee
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 updated labeling to reflect the Post Approval Study Protocol.
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