Venovo Venous Stent System
FDA premarket approval P180037/S010 · decided 2022-05-20
Approval details
- PMA number
- P180037
- Supplement
- S010
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Venovo Venous Stent System
- Generic name
- Stent, iliac vein
- Applicant
- Bard Peripheral Vascular, Inc.
- Date received
- 2022-04-26
- Decision date
- 2022-05-20
- Days to decision
- 24 days
- Decision code
- OK30
- Product code
- QAN
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Tempe, AZ
- Statement
- Delivery system manufacturing process and inspection changes for the 9 French device size.
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