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 an alternate sterilization site located at sterigenics uk limited cotes park lane somercotes, alfreton de55 4nj united kingdom.
| Device | StarClose SE Vascular Surgical System |
| Classification Name | Device, Hemostasis, Vascular |
| Generic Name | Device, Hemostasis, Vascular |
| Applicant | ABBOTT VASCULAR DEVICES |
| Date Received | 2018-11-13 |
| Decision Date | 2019-02-21 |
| PMA | P050007 |
| Supplement | S037 |
| Product Code | MGB |
| Advisory Committee | Cardiovascular |
| Supplement Type | Normal 180 Day Track No User Fee |
| Supplement Reason | Location Change - Manufacturer/sterilizer/packager/supplier |
| 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 |