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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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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.
Classification Namestent, superficial femoral artery
Generic Namestent, superficial femoral artery
Medtronic Vascular
3576 unocal place
santa rosa, CA 95403
PMA NumberP110040
Date Received12/12/2011
Decision Date09/19/2013
Product Code
NIP[ Registered Establishments with NIP ]
Docket Number 13M-1159
Notice Date 09/23/2013
Advisory Committee Cardiovascular
Clinical Trials NCT00814970
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the medtronic vascular complete se vascular stent system. This device is indicated to improve luminal diameter in symptomatic patients with de novo and/or restenotic lesions or occlusions of the superficial femoral artery (sfa) or proximal popliteal artery (ppa) with reference diameters ranging from 4 mm to 7 mm and lesion lengths up to 140 mm.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S002 S003 S004 S005 S006 S007 S008 S009