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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 NumberS006
Date Received04/26/2010
Decision Date05/26/2010
Product Code
MJO[ Registered Establishments with MJO ]
Advisory Committee Orthopedic
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Upgrade of the rofin baasel software, which controls the etching machine, from version 1. 0. 54 to 1. 0. 61.
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