• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)

  • Print
  • Share
  • E-mail
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC

New Search Back to Search Results
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.
Classification Nameprosthesis, intervertebral disc
Generic Nameprosthesis, intervertebral disc
325 paramont drive
raynham, MA 02767
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
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
Summary Summary of Safety and Effectiveness
Labeling Labeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S002 S003 S004 S005