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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 NameABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM
Classification Namestent, iliac
ApplicantABBOTT VASCULAR INC.
PMA NumberP110028
Date Received07/25/2011
Decision Date02/22/2012
Product Code
NIO[ Registered Establishments with NIO ]
Docket Number 12M-0181
Notice Date 02/27/2012
Advisory Committee Cardiovascular
Clinical Trials NCT00844532
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Approval for the absolute pro vascular self-expanding stent system. The device is indicated for improving luminal diameter in patients with de novo or restenotic atherosclerotic lesions in the native common iliac artery and native external iliac artery with reference vessel diameters between 4. 3 mm and 9. 1 mm and lesions lengths up to 90 mm.
Approval Order Approval Order
Supplements: S001 S002 S003 S004 S005 S006 S007 S008 S009 
S010 S011 
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