PMA P200026S005
- Device
- Abre Venous Self-expanding Stent System
- Applicant
- Medtronic Vascular, Inc.
- PMA number
- P200026
- Supplement
- S005
- Product code
- QAN
- Decision date
- 2022-07-22
- Generic name
- Stent, iliac vein
- Approval order statement
- Approval for updates to the labeling to include long-term results from the ABRE Continued Follow-Up Study.
Current openFDA PMA Record#
- Device
- Abre Venous Self-expanding Stent System
- Applicant
- Medtronic Vascular, Inc.
- PMA number
- P200026
- Supplement
- S005
- Product code
- QAN
- Generic name
- Stent, iliac vein
- Decision date
- 2022-07-22
- Decision code
- APPR
- Date received
- 2022-06-17
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Approval order statement
- Approval for updates to the labeling to include long-term results from the ABRE Continued Follow-Up Study.