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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 ARTIFICIAL DISC
Generic NameProsthesis, intervertebral disc
ApplicantDepuy Spine, Inc.
325 Paramont Dr.
Raynham, MA 02767
PMA NumberP040006
Supplement NumberS004
Date Received03/08/2007
Decision Date09/05/2007
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) ADDITIONAL ENDPLATES WITH LARGER FOOTPRINT, LATERAL PLACEMENT OF FIXATION TEETH, AND 1 MM OFFSET ARTICULATING SURFACE; 2) ADDITIONAL CORES WITH MODIFIED OUTER RIM; 3) MODIFIED SURGICAL INSTRUMENTS TO ACCOMMODATE MODIFIED DEVICE COMPONENTS; AND 4) MODIFIED SURGICAL TECHNIQUE.
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