Approval for the angiojet(r) rheolytic(tm) thrombectomy system (angiojet(r) drive unite, angiojet(r) pump set, and angiojet(r) rheolytic(tm) thrombectomy lf140 catheter). This device is indicated for removing thrombus in the treatment of patients with symptomatic coronary artery or saphenous vein graft lesion in vessels > 2. 0mm in diameter prior to balloon angioplasty or stent placement.
| Device | ANGIOJET RHEOLYTIC THROMBECTOMY LF140 CATHETER |
| Classification Name | Catheter, Coronary, Atherectomy |
| Generic Name | Catheter, Coronary, Atherectomy |
| Applicant | Boston Scientific Corp. |
| Date Received | 1998-09-14 |
| Decision Date | 1999-03-12 |
| Notice Date | 1999-06-28 |
| PMA | P980037 |
| Supplement | S |
| Product Code | MCX |
| Docket Number | 99M-2015 |
| Advisory Committee | Cardiovascular |
| Expedited Review | Yes |
| Combination Product | No |
| Applicant Address | Boston Scientific Corp. 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 |
|---|
| P980037 | | Original Filing |
| S089 |
2022-11-09 |
30-day Notice |
| S088 |
2022-04-07 |
30-day Notice |
| S087 |
2022-02-04 |
30-day Notice |
| S086 |
2021-08-04 |
Normal 180 Day Track No User Fee |
| S085 |
2021-07-08 |
30-day Notice |
| S084 |
2020-12-03 |
30-day Notice |
| S083 |
2020-11-02 |
30-day Notice |
| S082 |
2020-10-16 |
30-day Notice |
| S081 |
2020-08-04 |
30-day Notice |
| S080 |
2020-03-16 |
30-day Notice |
| S079 | | |
| S078 |
2020-01-30 |
Normal 180 Day Track No User Fee |
| S077 |
2019-11-22 |
30-day Notice |
| S076 |
2019-09-25 |
30-day Notice |
| S075 |
2019-06-27 |
30-day Notice |
| S074 | | |
| S073 |
2019-04-29 |
Real-time Process |
| S072 |
2019-01-04 |
30-day Notice |
| S071 |
2018-10-24 |
30-day Notice |
| S070 |
2018-09-04 |
30-day Notice |
| S069 |
2018-01-12 |
30-day Notice |
| S068 |
2018-01-10 |
Special (immediate Track) |
| S067 |
2017-09-07 |
30-day Notice |
| S066 |
2017-07-18 |
Real-time Process |
| S065 |
2017-04-17 |
Normal 180 Day Track No User Fee |
| S064 |
2017-03-31 |
30-day Notice |
| S063 |
2017-01-09 |
30-day Notice |
| S062 |
2016-11-14 |
30-day Notice |
| S061 |
2016-11-02 |
30-day Notice |
| S060 |
2016-10-31 |
30-day Notice |
| S059 |
2016-10-20 |
135 Review Track For 30-day Notice |
| S058 |
2016-07-18 |
30-day Notice |
| S057 |
2016-03-07 |
Normal 180 Day Track No User Fee |
| S056 |
2016-01-14 |
30-day Notice |
| S055 |
2016-01-11 |
30-day Notice |
| S054 |
2015-11-27 |
30-day Notice |
| S053 |
2015-11-10 |
Normal 180 Day Track No User Fee |
| S052 |
2015-11-09 |
30-day Notice |
| S051 |
2015-11-05 |
30-day Notice |
| S050 |
2015-10-01 |
Normal 180 Day Track No User Fee |
| S049 |
2015-09-30 |
30-day Notice |
| S048 |
2015-08-21 |
30-day Notice |
| S047 |
2015-08-19 |
30-day Notice |
| S046 |
2015-06-18 |
135 Review Track For 30-day Notice |
| S045 |
2014-12-24 |
Real-time Process |
| S044 |
2014-11-18 |
135 Review Track For 30-day Notice |
| S043 |
2014-08-18 |
30-day Notice |
| S042 |
2014-06-03 |
Real-time Process |
| S041 |
2014-02-03 |
30-day Notice |
| S040 |
2012-08-15 |
Real-time Process |
| S039 |
2011-11-15 |
Normal 180 Day Track |
| S038 |
2011-07-05 |
Normal 180 Day Track |
| S037 |
2011-05-23 |
30-day Notice |
| S036 |
2011-05-20 |
Real-time Process |
| S035 |
2011-02-08 |
Real-time Process |
| S034 |
2011-01-18 |
Real-time Process |
| S033 |
2009-11-05 |
30-day Notice |
| S032 |
2009-06-10 |
Real-time Process |
| S031 |
2009-05-27 |
Real-time Process |
| S030 |
2009-04-27 |
Real-time Process |
| S029 |
2009-02-06 |
30-day Notice |
| S028 |
2009-01-27 |
30-day Notice |
| S027 |
2008-07-16 |
Normal 180 Day Track |
| S026 |
2008-07-07 |
30-day Notice |
| S025 |
2008-01-28 |
Real-time Process |
| S024 |
2007-12-20 |
Normal 180 Day Track |
| S023 |
2007-07-03 |
30-day Notice |
| S022 |
2007-03-05 |
Real-time Process |
| S021 |
2006-12-07 |
Real-time Process |
| S020 |
2006-09-29 |
Normal 180 Day Track |
| S019 |
2006-08-14 |
135 Review Track For 30-day Notice |
| S018 | | |
| S017 |
2005-11-29 |
Real-time Process |
| S016 |
2005-10-17 |
Normal 180 Day Track |
| S015 |
2005-10-03 |
Real-time Process |
| S014 |
2005-08-01 |
Normal 180 Day Track |
| S013 |
2005-05-02 |
Real-time Process |
| S012 |
2005-01-07 |
30-day Notice |
| S011 |
2004-06-16 |
Special (immediate Track) |
| S010 |
2004-05-19 |
Real-time Process |
| S009 |
2004-05-19 |
Real-time Process |
| S008 |
2004-05-19 |
Real-time Process |
| S007 |
2003-11-26 |
Normal 180 Day Track |
| S006 |
2002-12-18 |
Special (immediate Track) |
| S005 | | |
| S004 |
2001-01-31 |
Normal 180 Day Track |
| S003 |
2000-12-19 |
Normal 180 Day Track |
| S002 |
2000-02-29 |
Special (immediate Track) |
| S001 |
1999-11-02 |
Normal 180 Day Track |
NIH GUDID Devices