PMA P110023S069

Device: EverFlex™ Self-Expanding Peripheral Stent System; EverFlex™ Self-Expanding Peripheral Stent with Entrust™ Delivery Syste
Applicant: Medtronic Vascular, Inc.
PMA number: P110023
Supplement: S069
Product code: NIP
Decision date: 2026-10-16
Classification: Cardiovascular
Generic name: STENT, SUPERFICIAL FEMORAL ARTERY
Approval order statement: approval for a sterilization monitoring change to reduce incubation time for the biological indicator used in external process challenge devices

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: S069
Product code: NIP
Generic name: STENT, SUPERFICIAL FEMORAL ARTERY
Decision date: 2026-10-16
Decision code: OK30
Date received: 2026-09-17
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: approval for a sterilization monitoring change to reduce incubation time for the biological indicator used in external process challenge devices