Zilver Vascular Stent

FDA Premarket Approval P050017 S018

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

A change to the delivery system tip manufacturing process

DeviceZilver Vascular Stent
Generic NameStent, Iliac
ApplicantCook Incorporated
Date Received2020-01-08
Decision Date2020-02-07
Product CodeNIO 
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address Cook Incorporated p.o.box 489 bloomington, IN 47402

Supplemental Filings

Supplement NumberDateSupplement Type
P050017Original Filing
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
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

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