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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
PMA NumberP140002
Date Received03/11/2014
Decision Date05/22/2015
Product Code
NIP[ Registered Establishments with NIP ]
Docket Number 15M-1958
Notice Date 06/05/2015
Advisory Committee Cardiovascular
Clinical Trials NCT01118117
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Approval for the misago peripheral self-expanding stent system. This device is indicated to improve luminal diameter in symptomatic patients with de novo or restenotic native lesions or occlusions of the superficial femoral artery (sfa) and/or proximal popliteal artery with reference vessel diameters ranging from 4mm to 7mm and lesion length up to 150mm.
Approval Order Approval Order
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001