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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceCHARITE ARTIFICIAL DISC
Generic NameProsthesis, intervertebral disc
ApplicantDEPUY SPINE,INC
325 PARAMONT DRIVE
RAYNHAM, MA 02767
PMA NumberP040006
Date Received02/13/2004
Decision Date10/26/2004
Withdrawal Date 01/05/2012
Product Code MJO 
Docket Number 05M-0092
Notice Date 03/09/2005
Advisory Committee Orthopedic
Expedited Review Granted? Yes
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE CHARITE ARTIFICIAL DISC. THE DEVICE IS INDICATED FOR SPINAL ARTHROPLASTY IN SKELETALLY MATURE PATIENTS WITH DEGENERATIVE DISC DISEASE (DDD) AT ONE LEVEL FROM L4-S1. DDD IS DEFINED AS DISCOGENIC BACK PAIN WITH DEGENERATION OF THE DISC CONFIRMED BY PATIENT HISTORY AND RADIOGRAPHIC STUDIES. THESE DDD PATIENTS SHOULD HAVE NO MORE THAN 3 MM OF SPONDYLOLISTHESIS AT THE INVOLVED LEVEL. PATIENTS RECEIVING THE CHARITE ARTIFICIAL DISC SHOULD HAVE FAILED AT LEAST SIX MONTHS OF CONSERVATIVE TREATMENT PRIOR TO IMPLANTATION OF THE CHARITE ARTIFICIAL DISC.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
Supplements:  S001 S002 S003 S004 S005 
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