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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.
 
DeviceIN MOTION LUMBAR ARTIFICIAL DISC
Generic NameProsthesis, intervertebral disc
ApplicantDepuy Spine, Inc.
325 Paramont Dr.
Raynham, MA 02767
PMA NumberP040006
Supplement NumberS005
Date Received01/11/2011
Decision Date02/08/2011
Withdrawal Date01/05/2012
Product Code MJO 
Advisory Committee Orthopedic
Supplement TypeSpecial (Immediate Track)
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE CHANGE IN TOLERANCE OF THE IMPLANT DIMENSIONS AND THE SUBSEQUENT INDEPENDENT INSPECTION OF THESE DIMENSIONS.
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