PMA P180037S009
- Device
- Venovo Venous Stent System
- Applicant
- Bard Peripheral Vascular, Inc.
- PMA number
- P180037
- Supplement
- S009
- Product code
- QAN
- Decision date
- 2022-04-22
- Generic name
- Stent, iliac vein
- Approval order statement
- Delivery system manufacturing process and inspection changes for the 10 French device size.
Current openFDA PMA Record#
- Device
- Venovo Venous Stent System
- Applicant
- Bard Peripheral Vascular, Inc.
- PMA number
- P180037
- Supplement
- S009
- Product code
- QAN
- Generic name
- Stent, iliac vein
- Decision date
- 2022-04-22
- Decision code
- OK30
- Date received
- 2022-03-25
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Delivery system manufacturing process and inspection changes for the 10 French device size.