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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
6500 paseo padre parkway
fremont, CA 94555
PMA NumberP120002
Date Received02/03/2012
Decision Date11/07/2012
Product Code
NIP[ Registered Establishments with NIP ]
Docket Number 12M-1183
Notice Date 12/05/2012
Advisory Committee Cardiovascular
Clinical Trials NCT00739102
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the s. M. A. R. T. Control and s. M. A. R. T. Vascular stent systems. This device is indicated for use to improve luminal diameter in the treatment of patients with de novo or restenotic native lesion(s) of the superficial femoral artery and/or proximal popliteal artery with total length up to 150 mm and with a reference vessel diameter ranging from 4 mm to 7 mm.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S003 S004 S005 S006 S007 S008 S009 S010 
S011 S012