WALLSTENT TRANSJUGULAR PORTOSYSTEMICSHUNT (TIPS) ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM

Shunt, Portosystemic, Endoprosthesis

FDA Premarket Approval P930031 S034

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 new statistical process control software.

DeviceWALLSTENT TRANSJUGULAR PORTOSYSTEMICSHUNT (TIPS) ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM
Classification NameShunt, Portosystemic, Endoprosthesis
Generic NameShunt, Portosystemic, Endoprosthesis
ApplicantBoston Scientific Corp.
Date Received2012-08-13
Decision Date2012-09-06
PMAP930031
SupplementS034
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
S071 2022-11-14 30-day Notice
S070 2022-10-27 30-day Notice
S069 2022-06-03 30-day Notice
S068 2020-07-10 30-day Notice
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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