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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, renal
Generic Namestent, renal
3200 lakeside drive
santa clara, CA 95054
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
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
Summary Summary of Safety and Effectiveness
Labeling Labeling
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S002 S003 S004 S005 S006 S007 S008 S009 
S010 S011 S012