PRECISE NITINOL STENT SYSTEM

Stent, Carotid

FDA Premarket Approval P030047 S025

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 sealing equipment and additions to improve the visual inspection process.

DevicePRECISE NITINOL STENT SYSTEM
Classification NameStent, Carotid
Generic NameStent, Carotid
ApplicantCORDIS CORP.
Date Received2012-04-23
Decision Date2012-05-22
PMAP030047
SupplementS025
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
S046 2022-11-21 30-day Notice
S045 2022-11-07 30-day Notice
S044 2022-04-18 30-day Notice
S043 2022-01-14 Special (immediate Track)
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

NIH GUDID Devices

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