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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.
 
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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