Zilver PTX Drug-Eluting Peripheral Stent

FDA Premarket Approval P100022 S035

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

Changes to the process challenge devices used for routine sterilization processing and routine sterilization requalification

DeviceZilver PTX Drug-Eluting Peripheral Stent
Generic NameStent, Superficial Femoral Artery, Drug-eluting
ApplicantCook Ireland, Ltd.
Date Received2020-04-16
Decision Date2020-05-15
PMAP100022
SupplementS035
Product CodeNIU 
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product Yes
Applicant Address Cook Ireland, Ltd. o'halloran Road national Technology Park limerick 

Supplemental Filings

Supplement NumberDateSupplement Type
P100022Original Filing
S035 2020-04-16 30-day Notice
S034 2019-09-03 Special (immediate Track)
S033
S032 2018-12-26 Real-time Process
S031 2018-10-11 30-day Notice
S030 2018-10-09 Normal 180 Day Track No User Fee
S029 2018-08-09 30-day Notice
S028 2018-08-01 30-day Notice
S027 2018-05-29 Normal 180 Day Track
S026 2017-10-30 Normal 180 Day Track
S025 2017-06-01 Real-time Process
S024 2017-03-13 30-day Notice
S023 2017-03-07 30-day Notice
S022 2017-03-03 Real-time Process
S021 2016-11-18 Special (immediate Track)
S020 2016-07-05 Panel Track
S019
S018 2016-06-02 30-day Notice
S017 2016-03-15 30-day Notice
S016 2015-07-24 135 Review Track For 30-day Notice
S015 2015-07-15 Special (immediate Track)
S014 2015-06-18 Normal 180 Day Track
S013 2015-03-17 Normal 180 Day Track No User Fee
S012 2015-02-02 30-day Notice
S011 2014-11-12 Normal 180 Day Track No User Fee
S010 2014-04-17 Normal 180 Day Track No User Fee
S009 2013-09-20 30-day Notice
S008 2013-07-22 Real-time Process
S007 2013-06-24 30-day Notice
S006 2013-06-19 Special (immediate Track)
S005
S004 2012-12-13 Normal 180 Day Track No User Fee
S003 2012-12-13 Normal 180 Day Track No User Fee
S002 2012-12-11 Normal 180 Day Track
S001 2012-12-03 Normal 180 Day Track

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