PMA - Premarket Approval

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New Search Back to Search Results Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.   Trade Name LIFESTENT FLEXSTAR & FLEXSTAR XL VASCULAR STENT SYSTEM Classification Name stent, superficial femoral artery Generic Name peripheral(sfa) stent system Applicant BARD PERIPHERAL VASCULAR, INC. PMA Number P070014 Date Received 05/25/2007 Decision Date 02/13/2009 Product Code NIP [ Registered Establishments with NIP ] Docket Number 09M-0127 Notice Date 03/10/2009 Advisory Committee Cardiovascular Expedited Review Granted? No Information About: Labeling, Approval Order, Summary of Safety and Effectiveness Approval Order Statement  Approval for the lifestent flexstar and flexstar xl vascular stent system. The device is indicated for improvement of luminal diameter in the treatment of symptomatic de-novo or restenotic lesions up to 160 mm in length in the native superficial femoral artery (sfa) and proximal popliteal artery with reference vessel diameters ranging from 4. 00 - 6. 5 mm. Post-Approval Study Show Report Schedule and Study Progress Supplements: S001 S002 S003 S004