PMA P060001S052

Device: Protégé GPS self-expanding Peripheral Stent System
Applicant: Medtronic Vascular, Inc.
PMA number: P060001
Supplement: S052
Product code: NIM
Decision date: 2025-11-07
Classification: Cardiovascular
Generic name: Stent, carotid
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: Protégé GPS self-expanding Peripheral Stent System
Applicant: Medtronic Vascular, Inc.
PMA number: P060001
Supplement: S052
Product code: NIM
Generic name: Stent, carotid
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.