The transfer of your finished device manufacturing site from fremont, california to galway, ireland, the addition of new sterilization sites and cycles, and a change in legal manufacturer from veniti, inc. To boston scientific corporation.
| Device | VICI VENOUS STENT System and VICI RDS Stent System |
| Generic Name | Stent, Iliac Vein |
| Applicant | Boston Scientific Corporation |
| Date Received | 2020-07-22 |
| Decision Date | 2021-02-11 |
| PMA | P180013 |
| Supplement | S006 |
| Product Code | QAN |
| Advisory Committee | Cardiovascular |
| Supplement Type | Normal 180 Day Track No User Fee |
| Supplement Reason | Location Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Boston Scientific Corporation 300 Boston Scientific Way marlborough, MA 01752 |
Supplemental Filings
| 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 |
NIH GUDID Devices