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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 may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameCHARITE ARTIFICIAL DISC
Classification Nameprosthesis, intervertebral disc
Generic Namelumbar artificial disc
ApplicantDEPUY SPINE,INC
PMA NumberP040006
Date Received02/13/2004
Decision Date10/26/2004
Withdrawal Date 01/05/2012
Product Code
MJO[ Registered Establishments with MJO ]
Docket Number 05M-0092
Notice Date 03/09/2005
Advisory Committee Orthopedic
Expedited Review Granted? Yes
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
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 Order Approval Order
Supplements: S001 S002 S003 S004 S005 
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