Express SD Renal Premounted Stent System

FDA Premarket Approval P060006 S101

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

Updates to the stent crimper software and equipment

DeviceExpress SD Renal Premounted Stent System
Generic NameStent, Renal
ApplicantBoston Scientific Corp.
Date Received2020-08-06
Decision Date2020-08-17
PMAP060006
SupplementS101
Product CodeNIN 
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address Boston Scientific Corp. one Scimed Place maple Grove, MN 55311-1566

Supplemental Filings

Supplement NumberDateSupplement Type
P060006Original Filing
S101 2020-08-06 30-day Notice
S100 2020-03-12 Normal 180 Day Track No User Fee
S099 2020-02-11 30-day Notice
S098 2019-10-10 30-day Notice
S097 2019-06-27 30-day Notice
S096 2019-05-21 30-day Notice
S095 2018-12-03 30-day Notice
S094 2018-09-10 30-day Notice
S093 2018-08-24 30-day Notice
S092 2018-06-13 30-day Notice
S091 2018-04-06 135 Review Track For 30-day Notice
S090 2018-01-17 30-day Notice
S089 2017-11-20 30-day Notice
S088 2017-10-30 30-day Notice
S087 2017-10-02 30-day Notice
S086 2017-08-18 30-day Notice
S085 2017-08-04 30-day Notice
S084 2017-07-18 30-day Notice
S083 2017-06-26 30-day Notice
S082 2017-04-13 30-day Notice
S081 2017-04-11 30-day Notice
S080 2017-03-06 30-day Notice
S079 2017-02-16 30-day Notice
S078 2016-08-08 30-day Notice
S077 2016-07-21 30-day Notice
S076 2016-07-13 30-day Notice
S075 2016-06-15 Normal 180 Day Track No User Fee
S074 2016-06-13 30-day Notice
S073 2016-02-29 Real-time Process
S072 2016-02-18 30-day Notice
S071 2016-01-28 30-day Notice
S070 2015-09-02 Real-time Process
S069 2015-08-04 30-day Notice
S068
S067 2015-04-29 30-day Notice
S066 2015-02-23 30-day Notice
S065 2015-02-05 30-day Notice
S064 2014-11-14 135 Review Track For 30-day Notice
S063 2014-06-24 30-day Notice
S062 2014-06-13 Normal 180 Day Track No User Fee
S061 2014-06-02 30-day Notice
S060 2014-04-28 135 Review Track For 30-day Notice
S059 2014-03-31 30-day Notice
S058 2014-03-28 30-day Notice
S057 2014-02-25 30-day Notice
S056 2014-02-24 30-day Notice
S055 2014-02-21 30-day Notice
S054 2014-01-14 30-day Notice
S053 2013-12-30 30-day Notice
S052 2013-11-26 30-day Notice
S051 2013-11-25 30-day Notice
S050 2013-09-20 30-day Notice
S049 2013-09-19 30-day Notice
S048 2013-08-29 30-day Notice
S047 2013-06-10 30-day Notice
S046 2013-05-23 30-day Notice
S045
S044
S043 2013-03-29 Real-time Process
S042
S041 2013-01-28 30-day Notice
S040 2013-01-16 30-day Notice
S039 2012-11-27 30-day Notice
S038 2012-11-19 30-day Notice
S037 2012-11-16 30-day Notice
S036 2012-11-02 30-day Notice
S035 2012-10-15 30-day Notice
S034 2012-10-11 30-day Notice
S033 2012-09-05 30-day Notice
S032 2012-08-03 30-day Notice
S031 2012-07-13 135 Review Track For 30-day Notice
S030 2012-06-27 135 Review Track For 30-day Notice
S029 2012-06-06 30-day Notice
S028 2012-05-02 30-day Notice
S027 2012-04-27 30-day Notice
S026 2012-04-18 30-day Notice
S025 2012-03-23 30-day Notice
S024 2012-02-03 30-day Notice
S023 2011-11-14 30-day Notice
S022 2011-11-07 30-day Notice
S021 2011-06-21 Normal 180 Day Track No User Fee
S020 2011-04-01 30-day Notice
S019 2010-12-22 135 Review Track For 30-day Notice
S018 2010-12-14 30-day Notice
S017 2010-10-07 135 Review Track For 30-day Notice
S016 2010-09-13 30-day Notice
S015 2010-08-02 30-day Notice
S014 2010-06-07 135 Review Track For 30-day Notice
S013 2010-05-17 135 Review Track For 30-day Notice
S012 2010-04-15 30-day Notice
S011 2010-04-08 135 Review Track For 30-day Notice
S010 2010-03-08 Real-time Process
S009 2010-03-08 30-day Notice
S008
S007 2010-02-01 30-day Notice
S006 2010-01-27 Normal 180 Day Track
S005 2010-01-26 30-day Notice
S004 2009-11-10 135 Review Track For 30-day Notice
S003 2009-11-06 30-day Notice
S002 2009-11-05 30-day Notice
S001 2009-11-05 30-day Notice

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