Approval for improving luminal diameter in the iliofemoral veins for the treatment of symptomatic venous outflow obstruction.
| Device | VICI VENOUS STENT System |
| Classification Name | Stent, Iliac Vein |
| Generic Name | Stent, Iliac Vein |
| Applicant | Boston Scientific Corporation |
| Date Received | 2018-04-26 |
| Decision Date | 2019-05-02 |
| PMA | P180013 |
| Supplement | S |
| Product Code | QAN |
| Advisory Committee | Cardiovascular |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Boston Scientific Corporation 300 Boston Scientific Way marlborough, MA 01752 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling Labeling Part 2 |
| Approval Order: | Approval Order |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P180013 | Original Filing | |
| S007 | 2021-04-06 | Normal 180 Day Track No User Fee |
| S006 | 2020-07-22 | Normal 180 Day Track No User Fee |
| S005 | 2020-04-09 | Normal 180 Day Track No User Fee |
| S004 | ||
| S003 | 2019-11-21 | 30-day Notice |
| S002 | ||
| S001 | 2019-10-11 | 30-day Notice |
| Device ID | PMA | Supp |
|---|---|---|
| 00852725008171 | P180013 | 000 |
| 00852725008096 | P180013 | 000 |
| 00852725008102 | P180013 | 000 |
| 00852725008119 | P180013 | 000 |
| 00852725008126 | P180013 | 000 |
| 00852725008133 | P180013 | 000 |
| 00852725008140 | P180013 | 000 |
| 00852725008157 | P180013 | 000 |
| 00852725008164 | P180013 | 000 |
| 00852725008195 | P180013 | 004 |
| 00852725008201 | P180013 | 004 |
| 00852725008218 | P180013 | 004 |
| 00852725008225 | P180013 | 004 |
| 00852725008232 | P180013 | 004 |
| 00852725008249 | P180013 | 004 |
| 00852725008256 | P180013 | 004 |
| 00852725008263 | P180013 | 004 |
| 00852725008188 | P180013 | 004 |