PMA P200026S017
- Device
- Abre™ Venous Self-expanding Stent System
- Applicant
- Medtronic Vascular, Inc.
- PMA number
- P200026
- Supplement
- S017
- Product code
- QAN
- Decision date
- 2026-04-08
- Classification
- Cardiovascular
- Generic name
- Stent, iliac vein
- Approval order statement
- an additional repacking site and minor changes to the repack process
Current openFDA PMA Record#
- Device
- Abre™ Venous Self-expanding Stent System
- Applicant
- Medtronic Vascular, Inc.
- PMA number
- P200026
- Supplement
- S017
- Product code
- QAN
- Generic name
- Stent, iliac vein
- Decision date
- 2026-04-08
- Decision code
- OK30
- Date received
- 2026-03-30
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- an additional repacking site and minor changes to the repack process