Venovo Venous Stent System
FDA premarket approval P180037/S007 · decided 2021-11-19
Approval details
- PMA number
- P180037
- Supplement
- S007
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Trade name
- Venovo Venous Stent System
- Generic name
- Stent, iliac vein
- Applicant
- Bard Peripheral Vascular, Inc.
- Date received
- 2021-08-09
- Decision date
- 2021-11-19
- Days to decision
- 102 days
- Decision code
- APPR
- Product code
- QAN
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Tempe, AZ
- Statement
- Approval for updating the labeling to include the post-approval clinical data from the Vernacular study up to 3 years.
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