PMA P110023
- Device
- EverFlex™ Self-expanding Peripheral Stent System
- Applicant
- Medtronic Vascular, Inc.
- PMA number
- P110023
- Supplement
- S036
- Product code
- NIP
- Decision date
- 2026-07-10
- Generic name
- STENT, SUPERFICIAL FEMORAL ARTERY
- Approval order statement
- Changes to the fixture used with the Branson Ultrasonic Welder and manifold inspection associated with this process.
Current openFDA PMA Record#
- Device
- EverFlex™ Self-expanding Peripheral Stent System
- Applicant
- Medtronic Vascular, Inc.
- PMA number
- P110023
- Supplement
- S068
- Product code
- NIP
- Generic name
- STENT, SUPERFICIAL FEMORAL ARTERY
- Decision date
- 2026-07-10
- Decision code
- OK30
- Date received
- 2026-06-26
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Changes to the fixture used with the Branson Ultrasonic Welder and manifold inspection associated with this process.