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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.
 
DeviceCHARITE ARTIFICIAL DISC
Generic NameProsthesis, intervertebral disc
ApplicantDEPUY SPINE,INC
325 PARAMONT DRIVE
RAYNHAM, MA 02767
PMA NumberP040006
Supplement NumberS001
Date Received01/07/2005
Decision Date06/16/2005
Withdrawal Date 01/05/2012
Product Code MJO 
Advisory Committee Orthopedic
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Express GMP Supplement
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR A MANUFACTURING SITES LOCATED AT DEPUY (IRELAND) LTD, CORK, IRELAND, FOR MANUFACTURING AND ISOTRON PLC, MARCUS CLOSE, BERKSHIRE, UNITED KINGDOM, FOR STERILIZATION.
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