PMA P200026S001
- Device
- Abre Venous Self-expanding Stent System
- Applicant
- Medtronic Vascular, Inc.
- PMA number
- P200026
- Supplement
- S001
- Product code
- QAN
- Decision date
- 2021-05-07
- Generic name
- Stent, iliac vein
- Approval order statement
- New sterilization cycle with a reduced EO concentration using Chamber 31 and Chamber 32 at contract sterilizer.
Current openFDA PMA Record#
- Device
- Abre Venous Self-expanding Stent System
- Applicant
- Medtronic Vascular, Inc.
- PMA number
- P200026
- Supplement
- S001
- Product code
- QAN
- Generic name
- Stent, iliac vein
- Decision date
- 2021-05-07
- Decision code
- OK30
- Date received
- 2021-04-08
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- New sterilization cycle with a reduced EO concentration using Chamber 31 and Chamber 32 at contract sterilizer.