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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 NumberS012
Date Received04/26/2011
Decision Date07/10/2012
Product Code
MJO[ Registered Establishments with MJO ]
Advisory Committee Orthopedic
Supplement Typereal-time process
Supplement Reason labeling change - shelf-life
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for an alternative package configuration for the subject ablation catheters. The new package configuration would change the previous coiled tray configuration to a tray with a straight configuration. The device, as modified, will be marketed under the trade names safire blu sp irrigated ablation catheter, therapy cool path sp (bi-directional) ablation catheter, and safire blu duo sp ablation catheter.
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