PMA P110023S067

Device: Everflex™ Self-Expanding Peripheral Stent System, EverFlex™ Self-Expanding Peripheral Stent with Entrust™ Delivery Syste
Applicant: Medtronic Vascular, Inc.
PMA number: P110023
Supplement: S067
Product code: NIP
Decision date: 2026-04-23
Classification: Cardiovascular
Generic name: STENT, SUPERFICIAL FEMORAL ARTERY
Approval order statement: to change the stent mass removal process to a chemical etching method

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: S067
Product code: NIP
Generic name: STENT, SUPERFICIAL FEMORAL ARTERY
Decision date: 2026-04-23
Decision code: OK30
Date received: 2026-03-24
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: to change the stent mass removal process to a chemical etching method