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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.
 
DevicePRODISC TM-C TOTAL DISC REPLACEMENT
Classification Nameprosthesis, intervertebral disc
Generic Nameprosthesis, intervertebral disc
Applicant
SYNTHES SPINE
325 paramount drive
raynham, MA 02767
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
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
Summary Summary of Safety and Effectiveness
Labeling Labeling
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S002 S004 S005 S006 S007 S008 S009 S010 
S011 S012 S013 
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