- Device
- EverFlex Self-Expanding Peripheral Stent with Entrust Delivery System
- Applicant
- Medtronic Vascular, Inc.
- PMA number
- P110023
- Supplement
- S034
- Product code
- NIP
- Generic name
- STENT, SUPERFICIAL FEMORAL ARTERY
- Decision date
- 2022-06-07
- Decision code
- APPR
- Date received
- 2022-05-09
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for updates to the IFU to include a troubleshooting technique during partial deployment events