WALLSTENT IIIAC ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM

Stent, Coronary

FDA Premarket Approval P940019 S030

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 IIIAC ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM
Classification NameStent, Coronary
Generic NameStent, Coronary
ApplicantBOSTON SCIENTIFIC SCIMED, INC.
Date Received2012-09-05
Decision Date2012-09-21
PMAP940019
SupplementS030
Product CodeMAF
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address BOSTON SCIENTIFIC SCIMED, INC. one Scimed Place maple Grove, MN 55311-1566

Supplemental Filings

Supplement NumberDateSupplement Type
P940019Original Filing
S062 2022-11-14 30-day Notice
S061 2022-10-27 30-day Notice
S060 2022-06-03 30-day Notice
S059 2020-07-10 30-day Notice
S058 2020-06-16 30-day Notice
S057 2019-09-30 30-day Notice
S056 2019-06-27 30-day Notice
S055 2019-05-03 30-day Notice
S054 2019-03-22 30-day Notice
S053 2018-11-21 30-day Notice
S052 2018-11-21 30-day Notice
S051 2017-06-19 30-day Notice
S050 2017-06-01 30-day Notice
S049 2016-10-03 30-day Notice
S048 2016-09-13 30-day Notice
S047 2016-07-26 30-day Notice
S046
S045
S044 2014-04-25 30-day Notice
S043 2013-11-26 30-day Notice
S042 2013-11-25 30-day Notice
S041 2013-09-20 30-day Notice
S040 2013-08-29 30-day Notice
S039 2013-06-10 30-day Notice
S038 2013-05-28 30-day Notice
S037 2013-05-09 30-day Notice
S036 2013-03-21 30-day Notice
S035 2012-11-27 135 Review Track For 30-day Notice
S034 2012-11-19 30-day Notice
S033 2012-11-19 30-day Notice
S032 2012-10-15 30-day Notice
S031 2012-09-28 30-day Notice
S030 2012-09-05 30-day Notice
S029 2012-08-13 30-day Notice
S028 2012-06-15 30-day Notice
S027 2012-06-13 30-day Notice
S026 2011-07-07 30-day Notice
S025 2011-06-20 Real-time Process
S024 2011-02-10 135 Review Track For 30-day Notice
S023 2010-04-08 135 Review Track For 30-day Notice
S022 2010-01-26 30-day Notice
S021 2007-08-13 Special (immediate Track)
S020 2006-05-09 30-day Notice
S019 2005-03-14 Normal 180 Day Track No User Fee
S018 2004-12-20 30-day Notice
S017 2003-12-08 30-day Notice
S016 2003-11-17 Normal 180 Day Track No User Fee
S015 2003-08-14 30-day Notice
S014 2002-12-18 30-day Notice
S013 2002-12-12 30-day Notice
S012 2002-05-29 30-day Notice
S011 2002-04-24 Normal 180 Day Track
S010 2002-01-09 Special (immediate Track)
S009 2001-12-20 Normal 180 Day Track
S008 2001-07-12 Special (immediate Track)
S007 2001-05-03 30-day Notice
S006
S005 1999-09-01 Normal 180 Day Track
S004 1998-09-14 Normal 180 Day Track
S003 1996-12-23 Normal 180 Day Track
S002 1996-10-15 Normal 180 Day Track
S001

NIH GUDID Devices

Device IDPMASupp
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