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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 -L TOTAL DISC REPLACEMENT DEVICE
Classification Nameprosthesis, intervertebral disc
Generic Nameprosthesis, intervertebral disc
Applicant
SYNTHES SPINE
325 paramount drive
raynham, MA 02767
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
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
Summary Summary of Safety and Effectiveness
Labeling Labeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S002 S003 S005 S006 S007 S008 S009 S010 
S011 S012 S013 S014 S016 S017 
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