PMA P200026S015
- Device
- Abre Venous Self-expanding Stent System
- Applicant
- Medtronic Vascular, Inc.
- PMA number
- P200026
- Supplement
- S015
- Product code
- QAN
- Decision date
- 2025-12-12
- Classification
- Cardiovascular
- Generic name
- Stent, iliac vein
- Approval order statement
- Approval for the introduction of additional criteria to your austenite finish temperature for the 10, 12 and 14 mm stent diameter
Current openFDA PMA Record#
- Device
- Abre Venous Self-expanding Stent System
- Applicant
- Medtronic Vascular, Inc.
- PMA number
- P200026
- Supplement
- S015
- Product code
- QAN
- Generic name
- Stent, iliac vein
- Decision date
- 2025-12-12
- Decision code
- APPR
- Date received
- 2025-11-25
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for the introduction of additional criteria to your austenite finish temperature for the 10, 12 and 14 mm stent diameter