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.
| Device | StarClose SE Vascular Closure System |
| Generic Name | Device, Hemostasis, Vascular |
| Applicant | ABBOTT VASCULAR DEVICES3200 Lakeside Drivesanta Clara, CA 95054 PMA NumberP050007 Supplement NumberS043 Date Received11/21/2022 Decision Date01/31/2023 Product Code MGB Advisory Committee Cardiovascular Supplement Type135 Review Track For 30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2022-11-21 |
| Decision Date | 2023-01-31 |
| PMA | P050007 |
| Supplement | S043 |
| Product Code | MGB |
| Advisory Committee | Cardiovascular |
| Supplement Type | 135 Review Track For 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | ABBOTT VASCULAR DEVICES 3200 Lakeside Drive santa Clara, CA 95054 PMA NumberP050007 Supplement NumberS043 Date Received11/21/2022 Decision Date01/31/2023 Product Code MGB Advisory Committee Cardiovascular Supplement Type135 Review Track For 30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement Approval For A Change In Suppliers Adhesive Formulation And Manufacturing. |
| 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 |