PMA P110023S061

Device: EverFlex self-expanding Peripheral Stent System (EverFlex)
Applicant: Medtronic Vascular, Inc.
PMA number: P110023
Supplement: S061
Product code: NIP
Decision date: 2025-11-07
Classification: Cardiovascular
Generic name: STENT, SUPERFICIAL FEMORAL ARTERY
Approval order statement: Approval for an alternate modified stopcock from the supplier for the EverFlex self-expanding Peripheral Stent System and Protégé GPS Self-Expanding Peripheral Stent System.

Current openFDA PMA Record#

Device: EverFlex self-expanding Peripheral Stent System (EverFlex)
Applicant: Medtronic Vascular, Inc.
PMA number: P110023
Supplement: S061
Product code: NIP
Generic name: STENT, SUPERFICIAL FEMORAL ARTERY
Decision date: 2025-11-07
Decision code: APPR
Date received: 2025-08-14
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for an alternate modified stopcock from the supplier for the EverFlex self-expanding Peripheral Stent System and Protégé GPS Self-Expanding Peripheral Stent System.