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.
| Device | WALLSTENT ENDOPROSTHESIS |
| Classification Name | Stent, Coronary |
| Generic Name | Stent, Coronary |
| Applicant | BOSTON SCIENTIFIC CORPORATION |
| Date Received | 1998-08-03 |
| Decision Date | 2001-11-16 |
| Notice Date | 2002-05-09 |
| PMA | P980033 |
| Supplement | S |
| Product Code | MAF |
| Docket Number | 02M-0203 |
| Advisory Committee | Cardiovascular |
| Expedited Review | No |
| 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 Number | Date | Supplement Type |
|---|
| P980033 | | Original 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