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.
Transfer of bacterial endotoxin testing from the abbott facility (plymoth, mn) to the terumo puerto rico facility (caguas, pr) for angio-seal devices manufactured at the terumo puerto rico facility.
| Device | Angio Seal Vascular Closure |
| Classification Name | Device, Hemostasis, Vascular |
| Generic Name | Device, Hemostasis, Vascular |
| Applicant | TERUMO MEDICAL CORPORATION |
| Date Received | 2018-12-20 |
| Decision Date | 2019-01-17 |
| PMA | P930038 |
| Supplement | S090 |
| Product Code | MGB |
| Advisory Committee | Cardiovascular |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | TERUMO MEDICAL CORPORATION 950 Elkton Blvd. elkton, MD 21921 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P930038 | Original Filing | |
| S100 | 2022-07-28 | 30-day Notice |
| S099 | ||
| S098 | 2020-11-24 | 30-day Notice |
| S097 | 2019-11-18 | 30-day Notice |
| S096 | 2019-05-17 | 30-day Notice |
| S095 | 2019-04-26 | 30-day Notice |
| S094 | 2019-03-21 | 30-day Notice |
| S093 | 2019-02-28 | 30-day Notice |
| S092 | 2019-02-21 | 30-day Notice |
| S091 | 2019-01-22 | 30-day Notice |
| S090 | 2018-12-20 | 30-day Notice |
| S089 | 2018-07-16 | 30-day Notice |
| S088 | 2018-03-28 | 30-day Notice |
| S087 | 2018-03-05 | 30-day Notice |
| S086 | 2017-09-29 | 30-day Notice |
| S085 | 2017-09-25 | 30-day Notice |
| S084 | 2017-02-24 | Special (immediate Track) |
| S083 | 2016-11-07 | 135 Review Track For 30-day Notice |
| S082 | 2016-04-15 | 30-day Notice |
| S081 | 2016-04-11 | 30-day Notice |
| S080 | 2016-03-28 | 30-day Notice |
| S079 | 2016-02-01 | 30-day Notice |
| S078 | 2015-09-04 | Special (immediate Track) |
| S077 | 2015-08-21 | Normal 180 Day Track No User Fee |
| S076 | 2015-05-07 | 30-day Notice |
| S075 | 2015-02-25 | 30-day Notice |
| S074 | 2014-12-01 | 135 Review Track For 30-day Notice |
| S073 | ||
| S072 | 2014-02-21 | 30-day Notice |
| S071 | 2013-06-03 | 30-day Notice |
| S070 | 2012-01-17 | 30-day Notice |
| S069 | 2011-11-03 | 30-day Notice |
| S068 | 2011-08-09 | Real-time Process |
| S067 | 2011-07-05 | Normal 180 Day Track No User Fee |
| S066 | 2011-03-11 | 30-day Notice |
| S065 | 2011-01-27 | 30-day Notice |
| S064 | 2010-11-10 | Special (immediate Track) |
| S063 | 2010-07-28 | 30-day Notice |
| S062 | 2010-06-11 | 30-day Notice |
| S061 | 2010-01-25 | 30-day Notice |
| S060 | 2009-11-02 | 30-day Notice |
| S059 | ||
| S058 | 2009-04-15 | 30-day Notice |
| S057 | 2009-03-13 | 30-day Notice |
| S056 | ||
| S055 | 2008-05-09 | 30-day Notice |
| S054 | 2008-01-22 | Real-time Process |
| S053 | ||
| S052 | 2007-12-28 | Normal 180 Day Track |
| S051 | 2007-10-22 | 30-day Notice |
| S050 | 2007-04-06 | 30-day Notice |
| S049 | 2007-02-28 | 30-day Notice |
| S048 | 2006-10-31 | 135 Review Track For 30-day Notice |
| S047 | 2006-06-02 | 30-day Notice |
| S046 | 2005-10-12 | Normal 180 Day Track |
| S045 | 2005-08-02 | 30-day Notice |
| S044 | 2005-06-13 | Special (immediate Track) |
| S043 | 2005-02-08 | Real-time Process |
| S042 | 2005-01-25 | 135 Review Track For 30-day Notice |
| S041 | 2004-10-21 | Real-time Process |
| S040 | 2004-08-23 | Real-time Process |
| S039 | 2004-04-02 | Special (immediate Track) |
| S038 | 2004-03-10 | 30-day Notice |
| S037 | ||
| S036 | 2003-03-31 | Real-time Process |
| S035 | 2002-11-20 | Real-time Process |
| S034 | 2002-11-05 | Real-time Process |
| S033 | 2002-02-21 | Special (immediate Track) |
| S032 | 2001-09-06 | 30-day Notice |
| S031 | 2001-03-20 | Normal 180 Day Track |
| S030 | 2001-02-13 | 30-day Notice |
| S029 | 2001-01-08 | Normal 180 Day Track |
| S028 | 2000-12-18 | 30-day Notice |
| S027 | 2000-10-02 | Normal 180 Day Track |
| S026 | 2000-06-27 | Normal 180 Day Track |
| S025 | 2000-05-16 | Normal 180 Day Track |
| S024 | 2000-03-07 | Normal 180 Day Track |
| S023 | 2000-01-24 | Normal 180 Day Track |
| S022 | 1999-12-16 | Normal 180 Day Track |
| S021 | 1999-08-23 | 30-day Notice |
| S020 | 1999-07-19 | Normal 180 Day Track |
| S019 | 1999-06-28 | Normal 180 Day Track |
| S018 | 1999-04-05 | Normal 180 Day Track |
| S017 | 1998-08-07 | Real-time Process |
| S016 | 1998-06-24 | Special (immediate Track) |
| S015 | 1998-06-17 | Normal 180 Day Track |
| S014 | 1998-06-01 | Normal 180 Day Track |
| S013 | 1998-03-05 | Normal 180 Day Track |
| S012 | 1997-12-18 | Normal 180 Day Track |
| S011 | 1997-11-28 | Special (immediate Track) |
| S010 | 1997-11-25 | Normal 180 Day Track |
| S009 | 1997-10-24 | Special (immediate Track) |
| S008 | ||
| S007 | 1997-08-06 | Normal 180 Day Track |
| S006 | 1997-06-18 | Normal 180 Day Track |
| S005 | 1997-04-16 | Normal 180 Day Track |
| S004 | 1997-03-31 | Normal 180 Day Track |
| S003 | ||
| S002 | 1997-03-21 | |
| S001 | 1997-01-28 | Normal 180 Day Track |