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 changes tot he precautions and clinical procedure sections of the instructions for use.
| Device | PROSTAR TM 8FR AND 10FR PVS AND PROSTAR XL |
| Classification Name | Premarket Approval (PMA) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products Premarket Approval (PMA) Var MP = { Version: '1.0.22', Domains: {'es':'esp.fda.gov'}, SrcLang: 'en', UrlLang: 'mp_js_current_lang', SrcUr |
| Generic Name | Premarket Approval (PMA) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products Premarket Approval (PMA) Var MP = { Version: '1.0.22', Domains: {'es':'esp.fda.gov'}, SrcLang: 'en', UrlLang: 'mp_js_current_lang', SrcUr |
| Applicant | ABBOTT VASCULAR INC. |
| Date Received | 1997-10-02 |
| Decision Date | 1997-11-18 |
| PMA | P960043 |
| Supplement | S003 |
| Product Code | Premarket |
| Docket Number | Premarket Approval (PMA) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices Radia |
| Advisory Committee | Cardiovascular |
| Supplement Type | Special (immediate Track) |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | ABBOTT VASCULAR INC. 400 Saginaw Drive redwood City, CA 94063 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P960043 | Original Filing | |
| S120 | 2022-11-21 | 135 Review Track For 30-day Notice |
| S119 | 2022-11-16 | 30-day Notice |
| S118 | ||
| S117 | 2022-07-25 | 30-day Notice |
| S116 | 2022-06-15 | 30-day Notice |
| S115 | 2021-09-27 | 30-day Notice |
| S114 | 2021-08-23 | 30-day Notice |
| S113 | 2021-08-09 | 30-day Notice |
| S112 | ||
| S111 | 2021-01-29 | 30-day Notice |
| S110 | 2020-11-05 | 30-day Notice |
| S109 | 2020-09-04 | 30-day Notice |
| S108 | 2020-07-13 | 30-day Notice |
| S107 | ||
| S106 | 2019-07-26 | 30-day Notice |
| S105 | 2019-07-01 | 30-day Notice |
| S104 | 2019-04-24 | 30-day Notice |
| S103 | 2018-11-29 | 30-day Notice |
| S102 | 2018-11-13 | Normal 180 Day Track No User Fee |
| S101 | 2018-07-20 | Real-time Process |
| S100 | 2018-04-02 | 30-day Notice |
| S099 | 2017-11-16 | 30-day Notice |
| S098 | 2017-10-05 | 30-day Notice |
| S097 | 2017-07-28 | Panel Track |
| S096 | 2017-01-17 | 30-day Notice |
| S095 | 2016-11-21 | 30-day Notice |
| S094 | 2016-11-09 | 30-day Notice |
| S093 | 2016-06-09 | 30-day Notice |
| S092 | 2016-04-28 | 30-day Notice |
| S091 | 2015-11-09 | Normal 180 Day Track No User Fee |
| S090 | 2015-05-18 | Normal 180 Day Track No User Fee |
| S089 | 2014-11-17 | Real-time Process |
| S088 | 2014-03-18 | 30-day Notice |
| S087 | 2014-02-19 | 30-day Notice |
| S086 | 2014-01-03 | 30-day Notice |
| S085 | 2013-12-31 | 30-day Notice |
| S084 | 2013-08-26 | 30-day Notice |
| S083 | 2013-07-18 | 135 Review Track For 30-day Notice |
| S082 | 2013-07-01 | Real-time Process |
| S081 | ||
| S080 | 2012-07-20 | Panel Track |
| S079 | 2012-04-04 | 30-day Notice |
| S078 | 2012-04-03 | 30-day Notice |
| S077 | 2012-03-16 | 30-day Notice |
| S076 | 2011-10-24 | 30-day Notice |
| S075 | 2011-07-25 | Real-time Process |
| S074 | 2011-07-18 | 30-day Notice |
| S073 | 2011-06-30 | Real-time Process |
| S072 | 2010-12-06 | 30-day Notice |
| S071 | 2010-04-06 | 30-day Notice |
| S070 | 2009-11-27 | 30-day Notice |
| S069 | 2009-10-22 | 30-day Notice |
| S068 | 2009-10-05 | 30-day Notice |
| S067 | 2009-09-22 | 30-day Notice |
| S066 | 2009-08-04 | 30-day Notice |
| S065 | 2009-05-28 | Normal 180 Day Track No User Fee |
| S064 | 2008-08-15 | 30-day Notice |
| S063 | 2008-04-16 | Real-time Process |
| S062 | 2007-10-23 | 30-day Notice |
| S061 | 2007-10-23 | 30-day Notice |
| S060 | 2006-10-20 | Special (immediate Track) |
| S059 | 2006-07-06 | Special (immediate Track) |
| S058 | 2005-10-12 | Special (immediate Track) |
| S057 | 2005-07-11 | Special (immediate Track) |
| S056 | 2004-08-05 | Real-time Process |
| S055 | 2004-07-08 | Special (immediate Track) |
| S054 | 2004-07-02 | Real-time Process |
| S053 | 2004-03-15 | Special (immediate Track) |
| S052 | 2004-02-17 | Real-time Process |
| S051 | ||
| S050 | ||
| S049 | 2003-10-27 | Special (immediate Track) |
| S048 | 2003-09-08 | Normal 180 Day Track No User Fee |
| S047 | 2003-07-08 | Real-time Process |
| S046 | 2003-06-17 | Normal 180 Day Track |
| S045 | 2003-04-18 | Special (immediate Track) |
| S044 | 2003-03-03 | Real-time Process |
| S043 | 2002-11-18 | Real-time Process |
| S042 | 2002-10-08 | Real-time Process |
| S041 | 2002-07-26 | Normal 180 Day Track |
| S040 | 2002-04-26 | Real-time Process |
| S039 | 2002-04-17 | Real-time Process |
| S038 | 2002-03-26 | Real-time Process |
| S037 | 2002-01-14 | 30-day Notice |
| S036 | 2001-12-21 | Normal 180 Day Track |
| S035 | 2001-11-19 | Real-time Process |
| S034 | ||
| S033 | 2001-09-12 | 135 Review Track For 30-day Notice |
| S032 | 2001-07-26 | Real-time Process |
| S031 | 2001-01-29 | Normal 180 Day Track |
| S030 | 2000-12-26 | Real-time Process |
| S029 | 2000-11-29 | Normal 180 Day Track |
| S028 | 2000-11-13 | 30-day Notice |
| S027 | 2000-09-13 | Real-time Process |
| S026 | 2000-08-31 | Real-time Process |
| S025 | 2000-07-03 | Real-time Process |
| S024 | 2000-04-04 | Normal 180 Day Track |
| S023 | 2000-04-04 | Normal 180 Day Track |
| S022 | 2000-03-23 | Normal 180 Day Track |
| S021 | 1999-11-30 | Normal 180 Day Track |
| S020 | 1999-07-23 | Special (immediate Track) |
| S019 | 1999-05-03 | Normal 180 Day Track |
| S018 | 1999-04-22 | Special (immediate Track) |
| S017 | 1999-04-02 | Special (immediate Track) |
| S016 | 1999-01-08 | Normal 180 Day Track |
| S015 | 1998-12-17 | Normal 180 Day Track |
| S014 | 1998-11-16 | Special (immediate Track) |
| S013 | 1998-11-12 | Normal 180 Day Track |
| S012 | 1998-10-19 | Normal 180 Day Track |
| S011 | 1998-10-02 | Normal 180 Day Track |
| S010 | 1998-08-03 | Normal 180 Day Track |
| S009 | 1998-07-21 | Normal 180 Day Track |
| S008 | 1998-06-22 | Special (immediate Track) |
| S007 | 1998-04-15 | Normal 180 Day Track |
| S006 | 1998-03-13 | Normal 180 Day Track |
| S005 | 1998-03-09 | Normal 180 Day Track |
| S004 | ||
| S003 | 1997-10-02 | Special (immediate Track) |
| S002 | 1997-06-02 | Normal 180 Day Track |
| S001 | 1997-05-01 | Normal 180 Day Track |