PMA P110023S064

Device: EverFlex™ Self-Expanding Peripheral Stent System; EverFlex™ Self-Expanding Peripheral Stent with Entrust™ Delivery Syste
Applicant: Medtronic Vascular, Inc.
PMA number: P110023
Supplement: S064
Product code: NIP
Decision date: 2026-02-20
Classification: Cardiovascular
Generic name: STENT, SUPERFICIAL FEMORAL ARTERY
Approval order statement: approval to change an additive to an FEP resin used for heat shrink tubing

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: S064
Product code: NIP
Generic name: STENT, SUPERFICIAL FEMORAL ARTERY
Decision date: 2026-02-20
Decision code: OK30
Date received: 2026-01-23
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: approval to change an additive to an FEP resin used for heat shrink tubing