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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 NamePRODISC -L TOTAL DISC REPLACEMENT DEVICE
Classification Nameprosthesis, intervertebral disc
Generic Nameprosthesis,intervertebral disc
ApplicantSYNTHES SPINE
PMA NumberP050010
Date Received03/15/2005
Decision Date08/14/2006
Product Code
MJO[ Registered Establishments with MJO ]
Docket Number 06M-0343
Notice Date 08/25/2006
Advisory Committee Orthopedic
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Approval for the prodisc-l total disc replacement. The device is indicated for spinal arthroplasty in skeletally mature patients with degenerative disc disease (ddd) at one level from l3-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 grade 1 spondylolisthesis at the involved level. Patients receiving the prodisc-l total disc replacement should have failed at least six months of conservative treatment prior to implantation of the prodisc-l total disc replacement.
Approval Order Approval Order
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S002 S003 S005 S006 S007 S008 S009 S010 
S011 S012 
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