Bring manufacturing of an injection molded component in-house and replace the single- with the multi-cavity molding process.
| Device | EXOSEAL VASCULAR CLOSURE DEVICE (VCD) |
| Classification Name | Device, Hemostasis, Vascular |
| Generic Name | Device, Hemostasis, Vascular |
| Applicant | Cordis Corporation |
| Date Received | 2014-03-24 |
| Decision Date | 2014-04-23 |
| PMA | P100013 |
| Supplement | S010 |
| Product Code | MGB |
| Advisory Committee | Cardiovascular |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Cordis Corporation 1820 Mccarthy Boulevard milpitas, CA 95035 |
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