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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, iliac
Generic Namestent, iliac
6500 paseo padre parkway
fremont, CA 94555
PMA NumberP020036
Date Received09/05/2002
Decision Date08/12/2003
Product Code
NIO[ Registered Establishments with NIO ]
Docket Number 03M-0381
Notice Date 08/26/2003
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product No
Recalls CDRH Recalls
Approval Order Statement 
Approval for the s. M. A. R. T. Nitinol stent system and s. M. A. R. T. Control nitinol stent system. The devices are indicated for improving luminal diameter in patients with symptomatic atherosclerotic disease of the common and/or external iliac arteries up to 126 mm in length, with a reference vessel diameter of 4 to 9 mm, and angiographic evidence of a patient profunda or superficial femoral artery.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Labeling Part 2
Supplements: S001 S002 S003 S004 S005 S006 S008 S009 S010 
S011 S012 S013 S014 S015 S016 S017 S018 S019 
S020 S021 S022 S023 S024 S025 S026 S028 S029 
S030 S031 S032 S033 S034 S035 S036 S037