PMA P180013
- Device
- VICI VENOUS STENT System
- Applicant
- Boston Scientific Corporation
- PMA number
- P180013
- Supplement
- S007
- Product code
- QAN
- Decision date
- 2021-06-29
- Generic name
- Stent, iliac vein
- Approval order statement
- Approval for labeling update which incorporates the final 3-year results from the VIRTUS Continued Follow-Up Study of patients enrolled in the premarket study
Current openFDA PMA Record#
- Device
- VICI VENOUS STENT System
- Applicant
- Boston Scientific Corporation
- PMA number
- P180013
- Supplement
- S007
- Product code
- QAN
- Generic name
- Stent, iliac vein
- Decision date
- 2021-06-29
- Decision code
- APPR
- Date received
- 2021-04-06
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Approval order statement
- Approval for labeling update which incorporates the final 3-year results from the VIRTUS Continued Follow-Up Study of patients enrolled in the premarket study