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 modifications to the indications for use. The device, as modified, will be indicated for the following: the percutaneous closure of common femoral artery access sites while reducing times to hemostasis, ambulation, and dischargeability in patients who have undergone diagnostic endovascular catheterization procedures utilizing a 5f or 6f procedural sheath. The starclose vascular closure system is indicated for use to allow patients who have undergone diagnostic endovascular catheterization procedures to ambulate and be eligible for discharge as soon as possible after device placement. The starclose vascular closure system is indicated for the percutaneous closure of common femoral artery access sites while reducing times to hemostasis and ambulation, in patients who have undergone interventional endovascular catheterization procedures utilizing a 5f or 6f procedural sheath.
| Device | STARCLOSE AND STARCLOSE SE VASCULAR CLOSURE SYSTEMS |
| Classification Name | Device, Hemostasis, Vascular |
| Generic Name | Device, Hemostasis, Vascular |
| Applicant | ABBOTT VASCULAR DEVICES |
| Date Received | 2008-03-31 |
| Decision Date | 2008-08-25 |
| PMA | P050007 |
| Supplement | S009 |
| Product Code | MGB |
| 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 | Normal 180 Day Track |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | ABBOTT VASCULAR DEVICES 3200 Lakeside Drive santa Clara, CA 95054 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P050007 | Original Filing | |
| S043 | 2022-11-21 | 135 Review Track For 30-day Notice |
| S042 | 2022-11-16 | 30-day Notice |
| S041 | 2021-05-18 | 30-day Notice |
| S040 | 2020-11-05 | 30-day Notice |
| S039 | 2020-03-06 | 30-day Notice |
| S038 | 2019-04-24 | 30-day Notice |
| S037 | 2018-11-13 | Normal 180 Day Track No User Fee |
| S036 | 2018-04-02 | 30-day Notice |
| S035 | 2018-03-23 | 30-day Notice |
| S034 | 2016-11-21 | 30-day Notice |
| S033 | 2015-02-25 | Normal 180 Day Track No User Fee |
| S032 | 2014-09-12 | 30-day Notice |
| S031 | 2013-07-18 | 135 Review Track For 30-day Notice |
| S030 | 2012-06-12 | 30-day Notice |
| S029 | 2011-07-18 | 30-day Notice |
| S028 | 2011-02-22 | Special (immediate Track) |
| S027 | 2010-10-05 | Real-time Process |
| S026 | 2010-05-06 | 30-day Notice |
| S025 | 2010-04-23 | 30-day Notice |
| S024 | 2010-02-23 | Real-time Process |
| S023 | 2009-11-02 | Real-time Process |
| S022 | 2009-09-11 | 30-day Notice |
| S021 | 2009-09-10 | 30-day Notice |
| S020 | 2009-08-20 | 30-day Notice |
| S019 | 2009-08-04 | 30-day Notice |
| S018 | 2009-08-04 | 30-day Notice |
| S017 | 2009-07-22 | 30-day Notice |
| S016 | 2009-07-06 | 30-day Notice |
| S015 | 2009-06-30 | 135 Review Track For 30-day Notice |
| S014 | 2009-05-28 | Normal 180 Day Track No User Fee |
| S013 | 2009-03-02 | Real-time Process |
| S012 | 2008-08-22 | 30-day Notice |
| S011 | 2008-08-15 | 30-day Notice |
| S010 | 2008-07-02 | Special (immediate Track) |
| S009 | 2008-03-31 | Normal 180 Day Track |
| S008 | 2007-12-20 | 30-day Notice |
| S007 | 2007-12-12 | 30-day Notice |
| S006 | 2007-05-07 | Real-time Process |
| S005 | 2007-02-21 | 30-day Notice |
| S004 | 2006-10-24 | Real-time Process |
| S003 | 2006-07-05 | Real-time Process |
| S002 | 2006-02-09 | Special (immediate Track) |
| S001 | 2005-12-27 | Panel Track |