EXPRESS SD RENAL MONORAIL PREMOUNTED STENT SYSTEM

FDA Premarket Approval P060006 S009

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

Change to the method used to create the proximal marks on the shaft of the stent delivery system.

DeviceEXPRESS SD RENAL MONORAIL PREMOUNTED STENT SYSTEM
Generic NameStent, Renal
ApplicantBoston Scientific Corp.
Date Received2010-03-08
Decision Date2010-04-06
PMAP060006
SupplementS009
Product CodeNIN 
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
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
S104 2022-10-17 30-day Notice
S103 2022-01-28 30-day Notice
S102 2020-10-19 30-day Notice
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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