Omnilink Elite™ Vascular Balloon-Exoandable Stent System

FDA Premarket Approval P110043 S013

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

DeviceOmnilink Elite™ Vascular Balloon-Exoandable Stent System
Generic NameStent, Iliac
ApplicantABBOTT VASCULAR-CARDIAC THERAPIES3200 Lakeside Dr.santa Clara, CA 95054-2807 PMA NumberP110043 Supplement NumberS013 Date Received08/09/2022 Decision Date09/07/2022 Product Code NIO  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Date Received2022-08-09
Decision Date2022-09-07
PMAP110043
SupplementS013
Product CodeNIO 
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination ProductNo
Applicant AddressABBOTT VASCULAR-CARDIAC THERAPIES
3200 Lakeside Dr.
santa Clara, CA 95054-2807 PMA NumberP110043 Supplement NumberS013 Date Received08/09/2022 Decision Date09/07/2022 Product Code NIO  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement  
for The Addition Of Secondary Sterilization Equipment

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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