OMNILINK ELITE VACULAR SYSTEM

FDA Premarket Approval P110043 S006

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

Addition of receiving inspection and testing activities of raw materials and supply items at the clonmel, ireland facility and contract laboratories.

DeviceOMNILINK ELITE VACULAR SYSTEM
Generic NameStent, Iliac
ApplicantABBOTT VASCULAR-CARDIAC THERAPIES
Date Received2014-04-14
Decision Date2014-05-13
PMAP110043
SupplementS006
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

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