PMA P200026S004
- Device
- Abre Venous Self-expanding Stent System
- Applicant
- Medtronic Vascular, Inc.
- PMA number
- P200026
- Supplement
- S004
- Product code
- QAN
- Decision date
- 2022-02-11
- Generic name
- Stent, iliac vein
- Approval order statement
- Add an alternate test facility for hydrogen content testing of the nitinol tubing.
Current openFDA PMA Record#
- Device
- Abre Venous Self-expanding Stent System
- Applicant
- Medtronic Vascular, Inc.
- PMA number
- P200026
- Supplement
- S004
- Product code
- QAN
- Generic name
- Stent, iliac vein
- Decision date
- 2022-02-11
- Decision code
- OK30
- Date received
- 2022-01-28
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Add an alternate test facility for hydrogen content testing of the nitinol tubing.