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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.
 
DeviceEVERFLEX SELF-EXPANDING PERIPHERAL STENT WITH ENTRUST DELIVERY SYSTEM
Generic NameSTENT, SUPERFICIAL FEMORAL ARTERY
ApplicantMedtronic Vascular, Inc.
3033 Campus Dr.
Plymouth, MN 55441
PMA NumberP110023
Supplement NumberS012
Date Received08/22/2014
Decision Date04/29/2015
Product Code NIP 
Advisory Committee Cardiovascular
Clinical TrialsNCT02066740
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL TO ADD THE 5F ENTRUST OTW DELIVERY SYSTEM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME EVERFLEX SELF-EXPANDING PERIPHERAL STENT WITH ENTRUST DELIVERY SYSTEM AND IS INDICATED TO IMPROVE LUMINAL DIAMETER IN THE TREATMENT OF SYMPTOMATIC DE-NOVO OR RESTENOTIC LESIONS UP TO 140MM IN LENGTH IN THE NATIVE SUPERFICIAL FEMORAL ARTERY (SFA) AND/OR PROXIMAL POPLITEAL ARTERIES WITH REFERENCE VESSEL DIAMETERS RANGING FROM 4.5-7.5MM.
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