Cordis PRECISE Nitinol Stent System

FDA Premarket Approval P030047 S042

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 PRECISE Nitinol Stent System
Generic NameStent, Carotid
ApplicantCORDIS CORP.
Date Received2021-03-03
Decision Date2021-04-01
PMAP030047
SupplementS042
Product CodeNIM 
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
P030047Original Filing
S042 2021-03-03 30-day Notice
S041 2021-03-03 Special (immediate Track)
S040 2020-05-01 30-day Notice
S039 2019-05-24 30-day Notice
S038 2019-04-01 30-day Notice
S037
S036 2018-12-03 30-day Notice
S035 2018-02-26 30-day Notice
S034 2017-11-20 30-day Notice
S033 2016-11-01 30-day Notice
S032 2016-03-21 30-day Notice
S031 2015-05-01 30-day Notice
S030 2015-04-27 135 Review Track For 30-day Notice
S029 2015-03-19 135 Review Track For 30-day Notice
S028 2015-03-18 30-day Notice
S027 2014-09-23 30-day Notice
S026
S025 2012-04-23 30-day Notice
S024 2012-02-23 30-day Notice
S023 2012-01-09 30-day Notice
S022 2010-08-05 30-day Notice
S021 2010-07-29 30-day Notice
S020 2010-02-16 30-day Notice
S019 2010-02-16 Real-time Process
S018 2009-06-02 30-day Notice
S017 2009-03-26 30-day Notice
S016 2008-12-03 Special (immediate Track)
S015 2008-09-29 30-day Notice
S014 2008-07-15 30-day Notice
S013 2008-03-10 30-day Notice
S012 2008-02-06 135 Review Track For 30-day Notice
S011 2008-02-05 135 Review Track For 30-day Notice
S010 2007-12-17 30-day Notice
S009 2007-11-21 Normal 180 Day Track No User Fee
S008 2007-11-02 30-day Notice
S007 2007-10-09 30-day Notice
S006
S005 2007-08-27 Special (immediate Track)
S004 2007-05-31 30-day Notice
S003 2007-04-16 Normal 180 Day Track
S002 2007-02-21 30-day Notice
S001 2006-09-27 Normal 180 Day Track

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