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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 VASCULAR STENT SYSTEMS
Classification Namestent, superficial femoral artery
Generic Nameperipheral(sfa) stent system
ApplicantBARD PERIPHERAL VASCULAR, INC.
PMA NumberP070014
Supplement NumberS018
Date Received09/09/2010
Decision Date10/14/2010
Product Code
NIP[ Registered Establishments with NIP ]
Advisory Committee Cardiovascular
Clinical Trials NCT00673985
NCT01179984
Supplement Typenormal 180 day track no user fee
Supplement Reason labeling for post approval study
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a change in labeling that updates the instructions for use and the patient information brochure to include the most recent clinical data up to 3 years.
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