Venovo Venous Stent System
FDA premarket approval P180037/S008 · decided 2021-12-16
Approval details
- PMA number
- P180037
- Supplement
- S008
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Venovo Venous Stent System
- Generic name
- Stent, iliac vein
- Applicant
- Bard Peripheral Vascular, Inc.
- Date received
- 2021-10-15
- Decision date
- 2021-12-16
- Days to decision
- 62 days
- Decision code
- APPR
- Product code
- QAN
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Tempe, AZ
- Statement
- Approval for a change in configuration of the J1 joint of the delivery system.
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