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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameRX HERCULINK ELITE RENAL STENT SYSTEM
Classification Namestent, renal
ApplicantABBOTT VASCULAR-CARDIAC THERAPIES
PMA NumberP110001
Supplement NumberS011
Date Received12/11/2013
Decision Date06/06/2014
Product Code
NIN[ Registered Establishments with NIN ]
Advisory Committee Cardiovascular
Clinical Trials NCT00490841
Supplement Typenormal 180 day track no user fee
Supplement Reason labeling for post approval study
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a labeling update based on the post-approval study results.
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