Approval for percutaneous closure of femoral venous access sites while reducing time to ambulation, total post-procedure time, time to hemostasis, and time to discharge eligibility in patients who have undergone catheter-based procedures utilizing 6-12f inner diameter procedural sheaths, with single or multiple access sites in one or both limbs.
| Device | VASCADE MVP Venous Vascular Closure System (VVCS) |
| Classification Name | Device, Hemostasis, Vascular |
| Generic Name | Device, Hemostasis, Vascular |
| Applicant | CARDIVA MEDICAL, INC. |
| Date Received | 2018-05-30 |
| Decision Date | 2018-11-27 |
| Notice Date | 2018-12-06 |
| PMA | P120016 |
| Supplement | S024 |
| Product Code | MGB |
| Docket Number | 18M-4582 |
| Advisory Committee | Cardiovascular |
| Supplement Type | Panel Track |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | CARDIVA MEDICAL, INC. 2900 Lakeside Drive suite 160 santa Clara, CA 95054 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P120016 | | Original Filing |
| S030 |
2022-10-11 |
30-day Notice |
| S029 | | |
| S028 |
2021-02-08 |
Normal 180 Day Track |
| S027 |
2019-07-08 |
Normal 180 Day Track |
| S026 |
2018-11-23 |
Normal 180 Day Track No User Fee |
| S025 |
2018-07-10 |
Real-time Process |
| S024 |
2018-05-30 |
Panel Track |
| S023 |
2017-03-20 |
30-day Notice |
| S022 |
2017-01-17 |
30-day Notice |
| S021 |
2016-11-04 |
Normal 180 Day Track |
| S020 |
2016-06-03 |
Real-time Process |
| S019 |
2016-01-07 |
30-day Notice |
| S018 |
2015-11-16 |
30-day Notice |
| S017 |
2015-11-03 |
135 Review Track For 30-day Notice |
| S016 |
2015-06-29 |
Special (immediate Track) |
| S015 |
2015-05-18 |
Real-time Process |
| S014 |
2015-04-03 |
Normal 180 Day Track No User Fee |
| S013 |
2015-03-12 |
30-day Notice |
| S012 |
2015-03-03 |
30-day Notice |
| S011 |
2015-02-25 |
30-day Notice |
| S010 |
2015-02-18 |
30-day Notice |
| S009 |
2015-02-09 |
30-day Notice |
| S008 |
2014-12-12 |
30-day Notice |
| S007 |
2014-10-20 |
30-day Notice |
| S006 |
2014-09-29 |
30-day Notice |
| S005 |
2014-08-18 |
135 Review Track For 30-day Notice |
| S004 |
2014-08-18 |
Real-time Process |
| S003 |
2014-06-27 |
30-day Notice |
| S002 |
2014-03-31 |
Real-time Process |
| S001 |
2014-03-18 |
30-day Notice |
NIH GUDID Devices