Cordis S.M.A.R.T. CONTROL / S.M.A.R.T. Vascular Stent System

FDA Premarket Approval P120002 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

Approval for implementing recertification procedures for returned stents

DeviceCordis S.M.A.R.T. CONTROL / S.M.A.R.T. Vascular Stent System
Generic NameStent, Superficial Femoral Artery
Date Received2021-03-03
Decision Date2021-04-01
Product CodeNIP 
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address CORDIS CORP. 6500 Paseo Padre Parkway fremont, CA 94555

Supplemental Filings

Supplement NumberDateSupplement Type
P120002Original Filing
S019 2021-03-03 30-day Notice
S018 2020-09-25 30-day Notice
S017 2020-05-01 30-day Notice
S016 2019-05-24 30-day Notice
S015 2019-04-01 30-day Notice
S014 2018-12-03 30-day Notice
S013 2018-02-26 30-day Notice
S012 2016-03-21 30-day Notice
S011 2015-10-05 30-day Notice
S010 2015-05-01 30-day Notice
S009 2015-03-19 135 Review Track For 30-day Notice
S008 2015-03-18 30-day Notice
S007 2015-03-11 Normal 180 Day Track No User Fee
S006 2014-12-19 Normal 180 Day Track No User Fee
S005 2014-09-23 30-day Notice
S004 2014-05-12 30-day Notice
S003 2014-04-16 30-day Notice
S001 2014-03-24 30-day Notice


Device IDPMASupp
20705032024478 P120002 000
20705032024997 P120002 000
20705032025017 P120002 000
20705032025031 P120002 000
20705032025055 P120002 000
20705032063385 P120002 004
20705032063392 P120002 004
20705032063408 P120002 004
20705032063415 P120002 004
20705032063422 P120002 004
20705032063439 P120002 004

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