Venovo Venous Stent System
FDA premarket approval P180037 · decided 2019-03-13
Approval details
- PMA number
- P180037
- Trade name
- Venovo Venous Stent System
- Generic name
- Stent, iliac vein
- Applicant
- Bard Peripheral Vascular, Inc.
- Date received
- 2018-09-14
- Decision date
- 2019-03-13
- Days to decision
- 180 days
- Decision code
- APPR
- Product code
- QAN
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Tempe, AZ
- Statement
- Approval for the Venovo Venous Stent System. The device is indicated for the treatment of symptomatic iliofemoral venous outflow obstruction.
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