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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 -L TOTAL DISC REPLACEMENT
Classification Nameprosthesis, intervertebral disc
Generic Nameprosthesis,intervertebral disc
ApplicantSYNTHES SPINE
PMA NumberP050010
Supplement NumberS009
Date Received09/15/2010
Decision Date10/04/2011
Product Code
MJO[ Registered Establishments with MJO ]
Advisory Committee Orthopedic
Supplement Type135 review track for 30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a change from a manual polishing process to an automated polishing process and the addition of a passivation process after the plasma coating process.
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