PMA P110023S065
- Device
- EverFlex™ Self-Expanding Peripheral Stent System; EverFlex™ Self-Expanding Peripheral Stent with Entrust™ Delivery Syste
- Applicant
- Medtronic Vascular, Inc.
- PMA number
- P110023
- Supplement
- S065
- Product code
- NIP
- Decision date
- 2026-02-11
- Classification
- Cardiovascular
- Generic name
- STENT, SUPERFICIAL FEMORAL ARTERY
- Approval order statement
- a new fixture used in the stent microblasting process
Current openFDA PMA Record#
- Device
- EverFlex™ Self-Expanding Peripheral Stent System; EverFlex™ Self-Expanding Peripheral Stent with Entrust™ Delivery Syste
- Applicant
- Medtronic Vascular, Inc.
- PMA number
- P110023
- Supplement
- S065
- Product code
- NIP
- Generic name
- STENT, SUPERFICIAL FEMORAL ARTERY
- Decision date
- 2026-02-11
- Decision code
- OK30
- Date received
- 2026-01-29
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- a new fixture used in the stent microblasting process