Approval for the exoseal vascular closure device. This device is indicated as follows: the exoseal vascular closure device (vcd) is indicated for femoral artery puncture site closure, reducing times to hemostasis and ambulation in patients who have undergone diagnostic or interventional catheterization procedures using a standard 5f, 6f, or 7f vascular sheath introducer with up to 12 cm working length. Additionally, the exoseal vcd is indicated to reduce times to hemostasis and ambulation in patients who have undergone interventional catheterization procedures, using a standard 6f vascular sheath introducer up to a 12 cm working length, who have received preprocedural and/or intraprocedural glycoprotein (gp) iib/iiia inhibitor therapy.
| Device | CORDIS EXOSEAL VASCULAR CLOSURE DEVICE |
| Classification Name | Device, Hemostasis, Vascular |
| Generic Name | Device, Hemostasis, Vascular |
| Applicant | Cordis Corporation |
| Date Received | 2010-04-01 |
| Decision Date | 2011-05-19 |
| Notice Date | 2011-06-03 |
| PMA | P100013 |
| Supplement | S |
| Product Code | MGB |
| Docket Number | 11M-0430 |
| Advisory Committee | Cardiovascular |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Cordis Corporation 1820 Mccarthy Boulevard milpitas, CA 95035 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P100013 | | Original Filing |
| S026 |
2022-10-21 |
30-day Notice |
| S025 | | |
| S024 |
2022-01-31 |
30-day Notice |
| S023 |
2021-11-17 |
30-day Notice |
| S022 |
2021-10-27 |
30-day Notice |
| S021 |
2021-09-10 |
30-day Notice |
| S020 |
2019-05-24 |
30-day Notice |
| S019 |
2019-04-05 |
30-day Notice |
| S018 |
2019-02-28 |
30-day Notice |
| S017 |
2018-07-12 |
30-day Notice |
| S016 | | |
| S015 |
2017-08-11 |
Normal 180 Day Track No User Fee |
| S014 |
2017-04-11 |
135 Review Track For 30-day Notice |
| S013 |
2016-06-02 |
30-day Notice |
| S012 |
2015-07-23 |
30-day Notice |
| S011 | | |
| S010 |
2014-03-24 |
30-day Notice |
| S009 |
2013-04-09 |
30-day Notice |
| S008 |
2012-12-03 |
30-day Notice |
| S007 |
2012-11-13 |
30-day Notice |
| S006 |
2012-09-13 |
30-day Notice |
| S005 |
2012-07-16 |
30-day Notice |
| S004 |
2012-06-19 |
30-day Notice |
| S003 |
2011-12-12 |
Real-time Process |
| S002 |
2011-08-30 |
30-day Notice |
| S001 |
2011-07-28 |
30-day Notice |
NIH GUDID Devices