ZILVER VASCULAR STENT AND ZILVER VASCULAR STENT WITH RAPID EXCHANGE DELIVERY SYSTEM

Stent, Iliac

FDA Premarket Approval P050017 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

Approval for a product line extension that represents modifications to the 6fr version of the zilver vascular stent. In addition, approval of minor changes to the stent and delivery system and the addition of a 100 mm length stent. The device, as modified, will be marketed under the trade name zilver flex 35 vascular stent and is indicated for use as an adjunct to percutaneous transluminal angioplasty (pta) in the treatment of symptomatic vascular disease of the iliac arteries up to 100 mm in length, with a reference vessel diameter of 5 to 9 mm. Patients must be suitable for pta and stent treatment.

DeviceZILVER VASCULAR STENT AND ZILVER VASCULAR STENT WITH RAPID EXCHANGE DELIVERY SYSTEM
Classification NameStent, Iliac
Generic NameStent, Iliac
ApplicantCook Incorporated
Date Received2011-04-04
Decision Date2011-07-05
PMAP050017
SupplementS006
Product CodeNIO
Advisory CommitteeCardiovascular
Supplement TypeNormal 180 Day Track
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination Product No
Applicant Address Cook Incorporated p.o.box 489 bloomington, IN 47402

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

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