- Device
- Abre Venous self-expanding stent system
- Applicant
- Medtronic Vascular, Inc.
- PMA number
- P200026
- Supplement
- S003
- Product code
- QAN
- Generic name
- Stent, iliac vein
- Decision date
- 2021-11-05
- Decision code
- APPR
- Date received
- 2021-10-13
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for updates to the Instructions for Use (IFU) to provide clarifications and new information regarding vessel measurement and stent selection.