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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.
 
Trade NameCOMPLETE SE VASCULAR STENT SYSTEM
Classification Namestent, iliac
Generic Nameiliac stent
ApplicantMEDTRONIC VASCULAR
PMA NumberP090006
Date Received04/15/2009
Decision Date03/17/2010
Product Code
NIO[ Registered Establishments with NIO ]
Docket Number 10M-0158
Notice Date 03/26/2010
Advisory Committee Cardiovascular
Clinical Trials NCT00730730
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Approval for the complete se vascular stent system (20-100mm lengths). The device is indicated for improving luminal diameter in patients with iliac stenosis in previously unstented lesions with vessel reference diameters between 4. 5mm and 9. 5mm and lesion lengths up to 90mm.
Approval Order Approval Order
Supplements: S002 S003 S004 S005 S006 S007 S008 S009 S010 
S011 S012 S013 S014 
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