Zilver Vascular Stent

FDA Premarket Approval P050017 S019

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

DeviceZilver Vascular Stent
Generic NameStent, Iliac
ApplicantCook Ireland, Ltd.o'halloran Roadnational Technology Parklimerick  PMA NumberP050017 Supplement NumberS019 Date Received03/07/2022 Decision Date04/04/2022 Product Code NIO  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Date Received2022-03-07
Decision Date2022-04-04
PMAP050017
SupplementS019
Product CodeNIO 
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination ProductNo
Applicant AddressCook Ireland, Ltd.
o'halloran Road
national Technology Park
limerick  PMA NumberP050017 Supplement NumberS019 Date Received03/07/2022 Decision Date04/04/2022 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  
a Supplier Change For The Delivery System Tip Component

Supplemental Filings

Supplement NumberDateSupplement Type
P050017Original Filing
S019 2022-03-07 30-day Notice
S018 2020-01-08 30-day Notice
S017 2019-02-19 30-day Notice
S016 2018-05-30 30-day Notice
S015 2017-03-07 30-day Notice
S014 2016-11-18 Special (immediate Track)
S013 2016-06-02 30-day Notice
S012 2015-08-05 30-day Notice
S011 2015-07-15 Special (immediate Track)
S010 2014-07-15 30-day Notice
S009 2014-04-17 Normal 180 Day Track No User Fee
S008 2013-07-25 30-day Notice
S007
S006 2011-04-04 Normal 180 Day Track
S005 2010-02-19 Real-time Process
S004 2008-08-20 Normal 180 Day Track
S003 2008-07-10 Normal 180 Day Track No User Fee
S002 2008-03-10 Normal 180 Day Track No User Fee
S001 2007-10-11 30-day Notice

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