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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/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceRX HERCULINK ELITE RENAL STENT SYSTEM
Generic NameSTENT, RENAL
ApplicantABBOTT VASCULAR
3200 Lakeside Drive
Santa Clara, CA 95054
PMA NumberP110001
Date Received01/03/2011
Decision Date07/20/2011
Product Code NIN 
Docket Number 11M-0564
Notice Date 08/01/2011
Advisory Committee Cardiovascular
Clinical TrialsNCT00490841
Expedited Review Granted? No
Combination ProductNo
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 OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Post-Approval StudyShow Report Schedule and Study Progress
Supplements:  S001 S002 S003 S004 S005 S006 S007 S008 S009 S010 S011 
S012 S013 S014 S015 S016 S017 S018 S020 
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