ZILVER PTX DRUG-ELUTING PERIPHERAL STENT

Stent, Superficial Femoral Artery, Drug-eluting

FDA Premarket Approval P100022

This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.

Pre-market Approval Supplement Details

Approval for the zilver ptx drug-eluting peripheral stent. This device is indicated for improving luminal diameter for the treatment of de novo or restenotic symptomatic lesions in native vascular disease of the above-the-knee femoropopliteal arteries having reference vessel diameters from 4 mm to 9 mm and total lesion lengths up to 140 mm per limb and 280 mm per patient.

DeviceZILVER PTX DRUG-ELUTING PERIPHERAL STENT
Classification NameStent, Superficial Femoral Artery, Drug-eluting
Generic NameStent, Superficial Femoral Artery, Drug-eluting
ApplicantCOOK MEDICAL INCORPORATED
Date Received2010-06-04
Decision Date2012-11-14
Notice Date2012-11-30
PMAP100022
SupplementS
Product CodeNIU
Docket Number12M-1146
Advisory CommitteeCardiovascular
Expedited ReviewNo
Combination Product Yes
Applicant Address COOK MEDICAL INCORPORATED 750 Daniels Way p.o. Box 489 bloomington, IN 47402-0489
Summary:Summary of Safety and Effectiveness
Labeling: Labeling
Post-Approval Study:Show Report Schedule and Study Progress
Approval Order: Approval Order

Supplemental Filings

Supplement NumberDateSupplement Type
P100022Original Filing
S040 2021-11-04 Real-time Process
S039
S038 2021-08-11 Normal 180 Day Track No User Fee
S037 2020-11-20 30-day Notice
S036 2020-07-02 30-day Notice
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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