PMA P200026S019
- Device
- Abre™ Venous Self-Expanding Stent System
- Applicant
- Medtronic Vascular, Inc.
- PMA number
- P200026
- Supplement
- S019
- Product code
- QAN
- Decision date
- 2026-10-16
- Classification
- Cardiovascular
- Generic name
- Stent, iliac vein
- Approval order statement
- approval for a sterilization monitoring change to reduce incubation time for the biological indicator used in external process challenge devices
Current openFDA PMA Record#
- Device
- Abre™ Venous Self-Expanding Stent System
- Applicant
- Medtronic Vascular, Inc.
- PMA number
- P200026
- Supplement
- S019
- Product code
- QAN
- Generic name
- Stent, iliac vein
- Decision date
- 2026-10-16
- Decision code
- OK30
- Date received
- 2026-09-17
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- approval for a sterilization monitoring change to reduce incubation time for the biological indicator used in external process challenge devices