WALLSTENT ENDOPROSTHESIS

Stent, Coronary

FDA Premarket Approval P980033

This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.

Pre-market Approval Supplement Details

Approval for the wallstent venous endoprosthesis with unistep plus rp delivery system (10 mm venous endoprosthesis) and the wallstent venous endoprosthesis with unistep plus delivery systems (12 mm - 16 mm venous endoprostheses). These devices are indicated for improving central venous luminal diameter following unseccessful angioplasty in patients on chronic hemodialysis with stenosis of the venous outflow tract. Unsuccessful angioplasty is defined as residual stenosis >= 30 percent for a vein = 50 percent for a vein > 10 mm in diameter, a tear which interrupts the integrity of the intima or lumen, abrupt lesion site occlusion, or refractory spasm. The vessels that can be treated with the device are the innominate and subclavian veins ranging from 8 mm to 15 mm in diameter.

DeviceWALLSTENT ENDOPROSTHESIS
Classification NameStent, Coronary
Generic NameStent, Coronary
ApplicantBOSTON SCIENTIFIC CORPORATION
Date Received1998-08-03
Decision Date2001-11-16
Notice Date2002-05-09
PMAP980033
SupplementS
Product CodeMAF
Docket Number02M-0203
Advisory CommitteeCardiovascular
Expedited ReviewNo
Combination Product No
Applicant Address BOSTON SCIENTIFIC CORPORATION one Scimed Place maple Grove, MN 55311-1566
Summary:Summary of Safety and Effectiveness
Labeling: Labeling
Approval Order: Approval Order

Supplemental Filings

Supplement NumberDateSupplement Type
P980033Original Filing
S061 2022-11-14 30-day Notice
S060 2022-09-14 30-day Notice
S059 2022-06-03 30-day Notice
S058 2020-07-10 30-day Notice
S057 2020-06-16 30-day Notice
S056 2019-09-30 30-day Notice
S055 2019-06-27 30-day Notice
S054 2019-05-03 30-day Notice
S053 2019-03-22 30-day Notice
S052 2018-11-21 30-day Notice
S051 2018-11-21 30-day Notice
S050
S049 2017-06-19 30-day Notice
S048 2017-06-01 30-day Notice
S047 2016-10-03 30-day Notice
S046 2016-09-13 30-day Notice
S045 2016-07-26 30-day Notice
S044
S043 2015-03-09 Real-time Process
S042
S041 2014-04-25 30-day Notice
S040 2013-11-26 30-day Notice
S039 2013-11-25 30-day Notice
S038 2013-11-04 30-day Notice
S037 2013-09-20 30-day Notice
S036 2013-08-29 30-day Notice
S035 2013-06-19 30-day Notice
S034 2013-06-10 30-day Notice
S033 2013-05-28 30-day Notice
S032 2013-05-09 30-day Notice
S031 2013-03-21 30-day Notice
S030 2013-01-15 30-day Notice
S029 2012-11-27 135 Review Track For 30-day Notice
S028 2012-11-19 30-day Notice
S027 2012-11-19 30-day Notice
S026 2012-10-15 30-day Notice
S025 2012-09-28 30-day Notice
S024 2012-09-05 30-day Notice
S023 2012-08-13 30-day Notice
S022 2012-06-15 30-day Notice
S021 2012-06-13 30-day Notice
S020 2012-04-18 30-day Notice
S019 2011-07-07 30-day Notice
S018 2011-02-10 135 Review Track For 30-day Notice
S017 2010-04-08 135 Review Track For 30-day Notice
S016 2010-01-26 30-day Notice
S015 2008-11-19 30-day Notice
S014 2006-05-09 30-day Notice
S013 2005-03-14 Normal 180 Day Track No User Fee
S012 2004-12-20 30-day Notice
S011 2004-06-25 30-day Notice
S010 2004-04-09 30-day Notice
S009 2003-12-08 30-day Notice
S008 2003-11-17 Normal 180 Day Track No User Fee
S007 2003-08-14 30-day Notice
S006 2003-03-12 Special (immediate Track)
S005 2002-12-18 30-day Notice
S004 2002-12-12 30-day Notice
S003 2002-05-29 30-day Notice
S002 2002-04-24 Normal 180 Day Track
S001 2001-12-20 Normal 180 Day Track

NIH GUDID Devices

Device IDPMASupp
08714729979647 P980033 050
08714729979500 P980033 050
08714729979494 P980033 050
08714729979487 P980033 050
08714729979470 P980033 050
08714729979463 P980033 050
08714729979456 P980033 050
08714729979449 P980033 050
08714729979432 P980033 050
08714729979425 P980033 050
08714729979418 P980033 050
08714729979517 P980033 050
08714729979524 P980033 050
08714729979531 P980033 050
08714729979630 P980033 050
08714729979623 P980033 050
08714729979616 P980033 050
08714729979609 P980033 050
08714729979593 P980033 050
08714729979586 P980033 050
08714729979579 P980033 050
08714729979562 P980033 050
08714729979555 P980033 050
08714729979548 P980033 050
08714729979401 P980033 050

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