- Device
- EverFlex Self-expanding Peripheral Stent System (SFA/PPA) and EverFlex Self-expanding Peripheral Stent System (iliac)
- Applicant
- Medtronic Vascular, Inc.
- PMA number
- P110023
- Supplement
- S029
- Product code
- NIP
- Generic name
- STENT, SUPERFICIAL FEMORAL ARTERY
- Decision date
- 2020-08-04
- Decision code
- APPR
- Date received
- 2020-05-06
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for changing a delivery system tensile strength specification.