Omnilink Elite OTW Stent System

FDA Premarket Approval P110043 S012

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

To change the resin of a molded component on the delivery system

DeviceOmnilink Elite OTW Stent System
Generic NameStent, Iliac
ApplicantABBOTT VASCULAR-CARDIAC THERAPIES
Date Received2020-08-14
Decision Date2020-09-11
PMAP110043
SupplementS012
Product CodeNIO 
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address ABBOTT VASCULAR-CARDIAC THERAPIES 3200 Lakeside Dr. santa Clara, CA 95054-2807

Supplemental Filings

Supplement NumberDateSupplement Type
P110043Original Filing
S012 2020-08-14 30-day Notice
S011 2016-08-19 30-day Notice
S010 2016-04-29 30-day Notice
S009 2014-09-02 30-day Notice
S008 0000-00-00
S007 0000-00-00
S006 2014-04-14 30-day Notice
S005
S004 2013-11-08 30-day Notice
S003 2012-10-01 Normal 180 Day Track No User Fee
S002 2012-08-27 30-day Notice
S001 2012-08-24 30-day Notice

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