Approval for an alternative hydrophilic coating material and supplier (dsm biomedical, gleen, netherlands) used on the distal shaft of the spiroflex family of catheters (spiroflex and sprioflex vg) and approval to perform the manufacturing coating process of the new dsm hydrophilic coating at the possis facility, minneapolis, minnesota.
| Device | ANGIOJET RHEOLYTIC THROMBECTOMY SYSTEN |
| Classification Name | Catheter, Coronary, Atherectomy |
| Generic Name | Catheter, Coronary, Atherectomy |
| Applicant | Boston Scientific Corp. |
| Date Received | 2007-12-20 |
| Decision Date | 2008-06-17 |
| PMA | P980037 |
| Supplement | S024 |
| Product Code | MCX |
| Advisory Committee | Cardiovascular |
| Supplement Type | Normal 180 Day Track |
| 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