Absolute Pro Vascular Self-Expanding Stent System

FDA Premarket Approval P110028 S021

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

Adding automated tab welding equipment and modifying tab weld geometry

DeviceAbsolute Pro Vascular Self-Expanding Stent System
Generic NameStent, Iliac
ApplicantABBOTT VASCULAR INC.
Date Received2020-08-05
Decision Date2020-08-28
PMAP110028
SupplementS021
Product CodeNIO 
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address ABBOTT VASCULAR INC. 3200 Lakeside Drive santa Clara, CA 92054

Supplemental Filings

Supplement NumberDateSupplement Type
P110028Original Filing
S021 2020-08-05 30-day Notice
S020 2019-07-05 30-day Notice
S019 2018-06-26 30-day Notice
S018 2017-03-21 30-day Notice
S017 2017-03-16 30-day Notice
S016 2015-04-07 135 Review Track For 30-day Notice
S015 2015-02-24 30-day Notice
S014 2015-01-14 30-day Notice
S013 2014-07-18 30-day Notice
S012 2014-05-07 135 Review Track For 30-day Notice
S011 2013-08-16 135 Review Track For 30-day Notice
S010 2013-08-14 30-day Notice
S009 2013-07-29 30-day Notice
S008 2013-05-31 30-day Notice
S007 2013-01-14 30-day Notice
S006 2012-12-19 30-day Notice
S005 2012-10-15 30-day Notice
S004 2012-06-13 30-day Notice
S003 2012-05-24 30-day Notice
S002 2012-05-21 30-day Notice
S001 2012-05-11 30-day Notice

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