This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.
Approval for the starclose vascular closure system. The device is indicated for 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.
| Device | STARCLOSE VASCULAR CLOSURE SYSTEM |
| Classification Name | Device, Hemostasis, Vascular |
| Generic Name | Device, Hemostasis, Vascular |
| Applicant | ABBOTT VASCULAR DEVICES |
| Date Received | 2005-02-28 |
| Decision Date | 2005-12-21 |
| Notice Date | 2006-01-13 |
| PMA | P050007 |
| Supplement | S |
| Product Code | MGB |
| Docket Number | 06M-0016 |
| Advisory Committee | Cardiovascular |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | ABBOTT VASCULAR DEVICES 3200 Lakeside Drive santa Clara, CA 95054 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
| 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 |