PMA P180037S007
- Device
- Venovo Venous Stent System
- Applicant
- Bard Peripheral Vascular, Inc.
- PMA number
- P180037
- Supplement
- S007
- Product code
- QAN
- Decision date
- 2021-11-19
- Generic name
- Stent, iliac vein
- Approval order statement
- Approval for updating the labeling to include the post-approval clinical data from the Vernacular study up to 3 years.
Current openFDA PMA Record#
- Device
- Venovo Venous Stent System
- Applicant
- Bard Peripheral Vascular, Inc.
- PMA number
- P180037
- Supplement
- S007
- Product code
- QAN
- Generic name
- Stent, iliac vein
- Decision date
- 2021-11-19
- Decision code
- APPR
- Date received
- 2021-08-09
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Approval order statement
- Approval for updating the labeling to include the post-approval clinical data from the Vernacular study up to 3 years.