This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.
| Device | AngioJet Spiroflex Thrombectomy Set, AngioJet Spiroflex VG Thrombectomy Set |
| Generic Name | Catheter, Coronary, Atherectomy |
| Applicant | Boston Scientific Corp.one Scimed Placemaple Grove, MN 55311-1566 PMA NumberP980037 Supplement NumberS089 Date Received11/09/2022 Decision Date12/07/2022 Product Code MCX Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2022-11-09 |
| Decision Date | 2022-12-07 |
| PMA | P980037 |
| Supplement | S089 |
| Product Code | MCX |
| Advisory Committee | Cardiovascular |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Boston Scientific Corp. one Scimed Place maple Grove, MN 55311-1566 PMA NumberP980037 Supplement NumberS089 Date Received11/09/2022 Decision Date12/07/2022 Product Code MCX Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement adding A New Component Supplier And Changes To The Existing Incoming Inspection Method And Criteria |
| 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 |
| Device ID | PMA | Supp |
|---|---|---|
| 08714729889151 | P980037 | 015 |
| 08714729889380 | P980037 | 022 |
| 08714729889441 | P980037 | 025 |
| 08714729889786 | P980037 | 039 |