Approval for the venaseal closure system. This device is indicated for the permanent closure of lower extremity superficial truncal veins, such as the great saphenous vein (gsv), through endovascular embolization with coaptation. Venaseal is intended for use in adults with clinically symptomatic venous reflux as diagnosed by duplex ultrasound (dus).
| Device | VENASEAL CLOSURE SYSTEM |
| Classification Name | Agent, Occluding, Vascular, Permanent |
| Generic Name | Agent, Occluding, Vascular, Permanent |
| Applicant | MEDTRONIC VASCULAR INC |
| Date Received | 2014-08-25 |
| Decision Date | 2015-02-20 |
| Notice Date | 2015-02-20 |
| PMA | P140018 |
| Supplement | S |
| Product Code | PJQ |
| Docket Number | 15M-0690 |
| Advisory Committee | Cardiovascular |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | MEDTRONIC VASCULAR INC 3033 Campus Drive plymouth, MN 55441 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling Labeling Part 2 |
| Approval Order: | Approval Order |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P140018 | | Original Filing |
| S036 |
2022-11-29 |
30-day Notice |
| S035 |
2022-10-12 |
30-day Notice |
| S034 |
2022-08-15 |
30-day Notice |
| S033 | | |
| S032 |
2022-04-29 |
Real-time Process |
| S031 |
2022-01-21 |
30-day Notice |
| S030 |
2021-11-30 |
30-day Notice |
| S029 | | |
| S028 |
2021-09-23 |
30-day Notice |
| S027 | | |
| S026 | | |
| S025 |
2021-04-23 |
Special (immediate Track) |
| S024 | | |
| S023 |
2021-02-25 |
30-day Notice |
| S022 | | |
| S021 |
2020-10-19 |
Real-time Process |
| S020 |
2020-08-24 |
30-day Notice |
| S019 |
2020-03-10 |
Special (immediate Track) |
| S018 |
2019-10-28 |
Normal 180 Day Track |
| S017 |
2019-09-25 |
Real-time Process |
| S016 |
2019-08-09 |
30-day Notice |
| S015 |
2019-05-24 |
30-day Notice |
| S014 |
2018-11-16 |
30-day Notice |
| S013 |
2018-09-24 |
30-day Notice |
| S012 |
2018-08-10 |
30-day Notice |
| S011 |
2018-03-27 |
30-day Notice |
| S010 |
2018-03-05 |
30-day Notice |
| S009 |
2018-02-26 |
30-day Notice |
| S008 |
2017-08-04 |
Normal 180 Day Track |
| S007 |
2017-06-13 |
Special (immediate Track) |
| S006 |
2017-05-18 |
Normal 180 Day Track No User Fee |
| S005 |
2016-11-01 |
30-day Notice |
| S004 |
2016-09-07 |
Normal 180 Day Track No User Fee |
| S003 |
2016-07-26 |
30-day Notice |
| S002 |
2016-06-27 |
30-day Notice |
| S001 |
2015-07-28 |
Real-time Process |
NIH GUDID Devices