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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 Dr.
Raynham, MA 02767
PMA NumberP040006
Supplement NumberS002
Date Received02/22/2005
Decision Date03/29/2006
Withdrawal Date01/05/2012
Product Code MJO 
Advisory Committee Orthopedic
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR 1) NEW ENDPLATES COATED WITH VACUUM PLASMA-SPRAYED PURE TITANIUM AND CALCIUM PHOSPHATE; 2) THREE NEW INTERMEDIATE ENDPLATE SIZES UTILIZING THIS SAME COATING; AND 3) VARIOUS SURGICAL INSTRUMENTS TO ACCOMMODATE THE PROPOSED NEW ENDPLATES.
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