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.
Approval for labeling changes
| Device | ANGIO-SEAL(TM)[1] HEMOSTATIC PUNCTURE CLOSURE DEVICE |
| Classification Name | Device, Hemostasis, Vascular |
| Generic Name | Device, Hemostasis, Vascular |
| Applicant | TERUMO MEDICAL CORPORATION |
| Date Received | 1997-03-21 |
| Decision Date | 1997-04-25 |
| PMA | P930038 |
| Supplement | S002 |
| Product Code | MGB |
| Advisory Committee | Cardiovascular |
| 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 |