PMA P180037
- Device
- Venovo Venous Stent System
- Applicant
- Bard Peripheral Vascular, Inc.
- PMA number
- P180037
- Supplement
- S012
- Product code
- QAN
- Decision date
- 2024-12-06
- Generic name
- Stent, iliac vein
- Approval order statement
- a change to the porosity and inclusions in the stent raw material specifications
Current openFDA PMA Record#
- Device
- Venovo Venous Stent System
- Applicant
- Bard Peripheral Vascular, Inc.
- PMA number
- P180037
- Supplement
- S014
- Product code
- QAN
- Generic name
- Stent, iliac vein
- Decision date
- 2024-12-06
- Decision code
- OK30
- Date received
- 2024-11-08
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- a change to the porosity and inclusions in the stent raw material specifications