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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 NameRX HERCULINK ELITE RENAL STENT SYSTEM
Classification Namestent, renal
ApplicantABBOTT VASCULAR
PMA NumberP110001
Date Received01/03/2011
Decision Date07/20/2011
Product Code
NIN[ Registered Establishments with NIN ]
Docket Number 11M-0564
Notice Date 08/01/2011
Advisory Committee Cardiovascular
Clinical Trials NCT00490841
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Approval for the rx herculink elite renal stent system. This device is indicated for use in patients with atherosclerotic disease of the renal arteries following sub-optimal percutaneous transluminal renal angioplasty (ptra) of a de novo or restenotic atherosclerotic lesion (<= 15 mm in length) located within 10 mm of the renal ostium and with a reference vessel diameter of 4. 0 - 7. 0 mm. Suboptimal ptra is defined as >= 50% residual stenosis, >= 20 mmhg peak systolic or >= 10 mmhg mean translesional pressure gradient, flow-limiting dissection, or timi [thrombolysis in myocardial infarction] flow <= 3.
Approval Order Approval Order
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S002 S003 S004 S005 S006 S007 S008 S009 
S010 
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