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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 NameLIFESTENT AND LIFESTENT XL VASCULAR STENT SYSTEMS
Classification Namestent, superficial femoral artery
Generic Nameperipheral(sfa) stent system
ApplicantBARD PERIPHERAL VASCULAR, INC.
PMA NumberP070014
Supplement NumberS001
Date Received06/04/2009
Decision Date07/30/2009
Product Code
NIP[ Registered Establishments with NIP ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason labeling change - minor
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to modify the name and package label for the lifestent vascular stent systems. Specifically, the word "flexstar" will be removed from the trade name and "& biliary" will be added to the device package labels to reflect the cleared biliary indication for this device. The device, as modified, will be marketed under the trade name lifestent vascular stent system and lifestent xl vascular stent system and is indicated for improvement of luminal diameter in the treatment of de-novo or restenotic lesion in the native sfa and proximal popliteal arteries.
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