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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-L TOTAL DISC REPLACEMENT
Generic NameProsthesis, intervertebral disc
ApplicantCentinel Spine, LLC
900 Airport Rd., Suite 3b
West Chester, PA 19380
PMA NumberP050010
Supplement NumberS012
Date Received04/26/2011
Decision Date07/10/2012
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 OF A PROTOCOL FOR EXTENSION OF SHELF-LIFE FOR THE POLYETHYLENE INLAY COMPONENT FROM THREE (3) YEARS TO FIVE (5) YEARS.
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