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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceBARD LIFESTENT VASCULAR STENT SYSTEM
Classification Namestent, superficial femoral artery
Generic Namestent, superficial femoral artery
Applicant
BARD PERIPHERAL VASCULAR, INC.
1415 west 3rd st.
tempe, AZ 85281
PMA NumberP070014
Supplement NumberS037
Date Received12/28/2012
Decision Date05/31/2016
Product Code
NIP[ Registered Establishments with NIP ]
Docket Number 16M-1455
Notice Date 06/03/2016
Advisory Committee Cardiovascular
Clinical Trials NCT00712309
Supplement Typepanel track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the Bard® LifeStent® Vascular Stent System. The Bard® LifeStent® Vascular Stent System is intended to improve luminal diameter in the treatment of symptomatic de novo or restenotic lesions up to 240 mm in length in the native superficial femoral artery (SFA) and popliteal artery with reference vessel diameters ranging from 4.0 to 6.5 mm.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
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