OMNILINK ELITE VASCULAR BALLOON-EXPANDABLE STENT SYSTEM

FDA Premarket Approval P110043 S008

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

Change to the pyrogen testing process.

DeviceOMNILINK ELITE VASCULAR BALLOON-EXPANDABLE STENT SYSTEM
Generic NameStent, Iliac
ApplicantABBOTT VASCULAR-CARDIAC THERAPIES
Date Received2014-08-27
Decision Date2014-10-09
PMAP110043
SupplementS008
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
S013 2022-08-09 30-day Notice
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 2014-08-27 30-day Notice
S007 2014-08-08 30-day Notice
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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.