Wallstent (Tips) Endoprosthesis With Unistep Plus Delivery System

FDA Premarket Approval P930031 S067

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

Use of an alternate extrusion line

DeviceWallstent (Tips) Endoprosthesis With Unistep Plus Delivery System
Generic NameShunt, Portosystemic, Endoprosthesis
ApplicantBoston Scientific Corp.
Date Received2020-06-16
Decision Date2020-06-25
PMAP930031
SupplementS067
Product CodeMIR 
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
P930031Original Filing
S067 2020-06-16 30-day Notice
S066 2019-09-30 30-day Notice
S065 2019-06-27 30-day Notice
S064 2019-05-03 30-day Notice
S063 2019-03-22 30-day Notice
S062 2018-11-21 30-day Notice
S061 2018-11-21 30-day Notice
S060 2017-06-19 30-day Notice
S059 2017-06-01 30-day Notice
S058 2016-10-03 30-day Notice
S057 2016-09-13 30-day Notice
S056 2016-07-26 30-day Notice
S055
S054 2015-03-09 Real-time Process
S053
S052 2014-04-25 30-day Notice
S051 2013-11-26 30-day Notice
S050 2013-11-25 30-day Notice
S049 2013-11-04 30-day Notice
S048 2013-09-20 30-day Notice
S047 2013-08-29 30-day Notice
S046 2013-06-19 30-day Notice
S045 2013-06-10 30-day Notice
S044 2013-05-28 30-day Notice
S043 2013-05-09 30-day Notice
S042 2013-03-21 30-day Notice
S041 2013-01-15 30-day Notice
S040 2012-11-27 135 Review Track For 30-day Notice
S039 2012-11-19 30-day Notice
S038 2012-11-19 30-day Notice
S037 2012-10-15 30-day Notice
S036 2012-09-28 30-day Notice
S035 2012-09-05 30-day Notice
S034 2012-08-13 30-day Notice
S033 2012-06-15 30-day Notice
S032 2012-06-13 30-day Notice
S031 2012-04-18 30-day Notice
S030 2011-07-07 30-day Notice
S029 2011-02-10 135 Review Track For 30-day Notice
S028 2010-04-08 135 Review Track For 30-day Notice
S027 2010-01-26 30-day Notice
S026 2008-11-19 30-day Notice
S025 2006-05-09 30-day Notice
S024 2005-03-14 Normal 180 Day Track No User Fee
S023 2004-12-20 30-day Notice
S022 2004-06-25 30-day Notice
S021 2004-04-09 30-day Notice
S020 2003-12-08 30-day Notice
S019
S018 2003-11-17 Normal 180 Day Track No User Fee
S017 2003-08-14 30-day Notice
S016 2002-12-18 30-day Notice
S015 2002-12-12 30-day Notice
S014 2002-05-29 30-day Notice
S013 2002-04-24 Normal 180 Day Track
S012 2002-01-09 Special (immediate Track)
S011 2001-12-20 Normal 180 Day Track
S010 2001-07-12 Special (immediate Track)
S009 2001-05-03 30-day Notice
S008
S007 1999-09-01 Normal 180 Day Track
S006 1998-08-12 Normal 180 Day Track
S005 1998-04-22 Normal 180 Day Track
S004 1996-10-15 Normal 180 Day Track
S003 1996-05-13 Normal 180 Day Track
S002 1996-04-04 Normal 180 Day Track
S001 1995-10-04 Normal 180 Day Track

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