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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.
 
DeviceSYNTHES PRODISC-C TOTAL DISC REPLACEMENT
Generic NameProsthesis, intervertebral disc
ApplicantCentinel Spine, LLC
900 Airport Road, Suite 3B
West Chester, PA 19380
PMA NumberP070001
Supplement NumberS013
Date Received04/03/2014
Decision Date08/27/2014
Product Code MJO 
Advisory Committee Orthopedic
Supplement Type135 Review Track For 30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR A CHANGE TO THE METHOD USED FOR ESTABLISHMENT OF THE BIOBURDEN ALERT AND ACTION LEVELS FOR DOSE AUDITING OF SYNTHES PRODISC-C AND PRODISC-L TOTAL DISC REPLACEMENT DEVICES.
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