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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 -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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