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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 TM-C TOTAL DISC REPLACEMENT
Classification Nameprosthesis, intervertebral disc
ApplicantSYNTHES SPINE
PMA NumberP070001
Date Received01/03/2007
Decision Date12/17/2007
Product Code
MJO[ Registered Establishments with MJO ]
Docket Number 08M-0013
Notice Date 01/10/2008
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-c total disc replacement. The device is indicated for skeletally mature patients for reconstruction of the disc from c3-c7 following single-level discectomy for intractable symptomatic cervical disc disease (scdd). Symptomatic cervical disc disease is defined as neck or arm (radicular) pain and/or a functional/neurological deficit with at least one of the following conditions confirmed by imaging (ct, mri, or x-rays): herniated nucleus pulposus, spondylosis (defined by the presence of osteophytes), and/or loss of disc height. The prodisc-c total disc replacement is implanted via an open anterior approach. Patients receiving the prodisc-c total disc replacement should have failed at least six weeks of non-operative treatment prior to implantation of the prodisc-c total disc replacement.
Approval Order Approval Order
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S002 S004 S005 S006 S007 S008 S009 S010 
S011 
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