RX Herculink Elite Renal and Biliary Stent System

FDA Premarket Approval P110001 S015

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.

Pre-market Approval Supplement Details

A change to the sub-assembly stent inspection process to increase manufacturing efficiency

DeviceRX Herculink Elite Renal and Biliary Stent System
Generic NameStent, Renal
ApplicantABBOTT VASCULAR
Date Received2021-04-29
Decision Date2021-06-22
PMAP110001
SupplementS015
Product CodeNIN 
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address ABBOTT VASCULAR 3200 Lakeside Drive santa Clara, CA 95054

Supplemental Filings

Supplement NumberDateSupplement Type
P110001Original Filing
S015 2021-04-29 30-day Notice
S014 2021-04-29 30-day Notice
S013 2017-03-21 30-day Notice
S012 2015-02-25 30-day Notice
S011 2013-12-11 Normal 180 Day Track No User Fee
S010 2012-12-19 30-day Notice
S009 2012-08-02 Normal 180 Day Track No User Fee
S008 2012-07-20 30-day Notice
S007 2012-06-13 30-day Notice
S006 2012-06-11 30-day Notice
S005 2012-05-24 30-day Notice
S004 2012-05-11 30-day Notice
S003 2012-04-27 Normal 180 Day Track No User Fee
S002 2011-11-21 30-day Notice
S001 2011-08-19 30-day Notice

© 2021 FDA.report
This site is not affiliated with or endorsed by the FDA.