Cordis S.M.A.R.T. CONTROL Nitinol Stent System

FDA Premarket Approval P020036 S043

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

To replace a supplier's winding equipment used to manufacture a component of the delivery system

DeviceCordis S.M.A.R.T. CONTROL Nitinol Stent System
Generic NameStent, Iliac
ApplicantCORDIS CORP.
Date Received2020-09-25
Decision Date2020-10-23
PMAP020036
SupplementS043
Product CodeNIO 
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
P020036Original Filing
S043 2020-09-25 30-day Notice
S042 2020-05-01 30-day Notice
S041 2019-05-24 30-day Notice
S040 2019-04-01 30-day Notice
S039 2018-12-03 30-day Notice
S038 2018-02-26 30-day Notice
S037 2016-05-02 Real-time Process
S036 2016-03-21 30-day Notice
S035 2015-10-05 30-day Notice
S034 2015-05-01 30-day Notice
S033 2015-03-19 135 Review Track For 30-day Notice
S032 2015-03-18 30-day Notice
S031 2014-12-19 Normal 180 Day Track No User Fee
S030 2014-09-23 30-day Notice
S029 2014-05-12 30-day Notice
S028 2014-04-16 30-day Notice
S027
S026 2014-03-24 30-day Notice
S025 2012-04-24 30-day Notice
S024 2012-04-23 30-day Notice
S023 2012-02-23 30-day Notice
S022 2012-01-09 30-day Notice
S021 2011-02-08 Real-time Process
S020 2010-08-09 135 Review Track For 30-day Notice
S019 2010-08-05 30-day Notice
S018 2010-07-29 30-day Notice
S017 2010-02-16 30-day Notice
S016 2010-03-30 Real-time Process
S015 2009-06-03 30-day Notice
S014 2009-04-09 30-day Notice
S013 2009-03-26 30-day Notice
S012 2008-12-03 Special (immediate Track)
S011 2008-09-29 30-day Notice
S010 2008-07-18 Special (immediate Track)
S009 2007-11-02 30-day Notice
S008 2007-08-24 Special (immediate Track)
S007
S006 2006-10-12 30-day Notice
S005 2006-08-11 30-day Notice
S004 2006-06-19 30-day Notice
S003 2006-06-19 30-day Notice
S002 2003-11-24 Real-time Process
S001 2003-10-29 Normal 180 Day Track No User Fee

NIH GUDID Devices

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