Express LD Premounted Iliac Stent System

FDA Premarket Approval P090003 S049

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 update final stent cleaning equipment and process

DeviceExpress LD Premounted Iliac Stent System
Generic NameStent, Iliac
ApplicantBOSTON SCIENTIFIC CORPORATION
Date Received2020-02-11
Decision Date2020-03-02
PMAP090003
SupplementS049
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
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

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