Express LD Iliac Premounted Stent System

Stent, Iliac

FDA Premarket Approval P090003 S045

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

Add an existing eo sterilization cycle to an additional chamber in order to increase cycle capacity.

DeviceExpress LD Iliac Premounted Stent System
Classification NameStent, Iliac
Generic NameStent, Iliac
ApplicantBOSTON SCIENTIFIC CORPORATION
Date Received2019-03-22
Decision Date2019-04-17
PMAP090003
SupplementS045
Product CodeNIO
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address BOSTON SCIENTIFIC CORPORATION one Scimed Place maple Grove, MN 55311

Supplemental Filings

Supplement NumberDateSupplement Type
P090003Original Filing
S053 2022-11-14 30-day Notice
S052 2022-08-19 30-day Notice
S051 2021-03-01 Real-time Process
S050 2020-10-19 30-day Notice
S049 2020-02-11 30-day Notice
S048 2019-06-27 30-day Notice
S047 2019-05-21 30-day Notice
S046 2019-05-03 30-day Notice
S045 2019-03-22 30-day Notice
S044 2018-09-10 30-day Notice
S043 2017-08-18 30-day Notice
S042 2016-06-15 Normal 180 Day Track No User Fee
S041 2016-06-13 30-day Notice
S040 2016-02-25 30-day Notice
S039 2016-02-18 30-day Notice
S038 2015-02-05 30-day Notice
S037 2014-11-14 135 Review Track For 30-day Notice
S036
S035 2014-07-22 Real-time Process
S034
S033 2014-06-02 30-day Notice
S032 2014-04-28 135 Review Track For 30-day Notice
S031 2014-04-07 30-day Notice
S030 2013-12-30 30-day Notice
S029 2013-09-30 Real-time Process
S028 2013-09-20 30-day Notice
S027 2013-08-29 30-day Notice
S026 2013-07-24 30-day Notice
S025 2013-06-19 30-day Notice
S024 2013-06-10 30-day Notice
S023
S022
S021 2013-02-04 30-day Notice
S020 2012-11-27 30-day Notice
S019 2012-11-19 30-day Notice
S018 2012-10-03 30-day Notice
S017 2012-09-28 30-day Notice
S016 2012-09-19 30-day Notice
S015 2012-08-13 30-day Notice
S014 2012-07-13 135 Review Track For 30-day Notice
S013 2012-07-05 30-day Notice
S012 2012-04-20 30-day Notice
S011 2011-04-29 30-day Notice
S010 2011-02-22 30-day Notice
S009 2011-02-08 30-day Notice
S008 2010-12-14 30-day Notice
S007 2010-09-13 30-day Notice
S006 2010-09-13 30-day Notice
S005 2010-07-06 135 Review Track For 30-day Notice
S004 2010-06-18 30-day Notice
S003 2010-05-17 135 Review Track For 30-day Notice
S002 2010-05-17 30-day Notice
S001 2010-04-15 30-day Notice

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.