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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NamePRODISC C TOTAL DISC REPLACEMENT
Classification Nameprosthesis, intervertebral disc
ApplicantSYNTHES SPINE
PMA NumberP070001
Supplement NumberS002
Date Received03/12/2008
Decision Date08/11/2008
Product Code
MJO[ Registered Establishments with MJO ]
Advisory Committee Orthopedic
Supplement Typenormal 180 day track no user fee
Supplement Reason pas protocal supplement osb
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval of the post-approval study.
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