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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 NameOMNILINK ELITE PERIPHERAL BALLOON-EXPANDABLE STENT SYSTEM
Classification Namestent, iliac
ApplicantABBOTT VASCULAR-CARDIAC THERAPIES
PMA NumberP110043
Date Received12/30/2011
Decision Date07/31/2012
Product Code
NIO[ Registered Establishments with NIO ]
Docket Number 12M-0833
Notice Date 08/03/2012
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 omnilink elite vascular balloon-expandable stent system. This device is indicated for the treatment of atherosclerotic iliac artery lesions with reference vessel diameters of >= 5. 0 mm and <= 11. 0 mm and lesion lengths up to 50 mm.
Approval Order Approval Order
Supplements: S001 S002 S003 
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