Approval for changing the packaging tray material for the angiojet ultra xmi, ultra spiroflex, and ultra spiroflex vg thrombectomy sets from petg to petg denest, as well as changing the manufacturing of these packaging trays from perfecseal to brookdale.
| Device | ANGIOJET RHEOLOYTIC THROMBECTOMY SYSTEM |
| Classification Name | Catheter, Coronary, Atherectomy |
| Generic Name | Catheter, Coronary, Atherectomy |
| Applicant | Boston Scientific Corp. |
| Date Received | 2012-08-15 |
| Decision Date | 2012-10-16 |
| PMA | P980037 |
| Supplement | S040 |
| Product Code | MCX |
| Advisory Committee | Cardiovascular |
| Supplement Type | Real-time Process |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Boston Scientific Corp. one Scimed Place maple Grove, MN 55311-1566 |
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