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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceRX HERCULINK ELITE RENAL STENT SYSTEM
Generic NameSTENT, RENAL
ApplicantAbbott Vascular
3200 Lakeside Dr.
Santa Clara, CA 95054
PMA NumberP110001
Supplement NumberS011
Date Received12/11/2013
Decision Date06/06/2014
Product Code NIN 
Advisory Committee Cardiovascular
Clinical TrialsNCT00490841
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Labeling Change - PAS
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR A LABELING UPDATE BASED ON THE POST-APPROVAL STUDY RESULTS.
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