PMA P060001S059

Device: Protégé™ GPS™ Self-Expanding Peripheral Stent System; Protégé™ RX Self-Expanding Carotid Stent System
Applicant: Medtronic Vascular, Inc.
PMA number: P060001
Supplement: S059
Product code: NIM
Decision date: 2026-10-16
Classification: Cardiovascular
Generic name: Stent, carotid
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: Protégé™ GPS™ Self-Expanding Peripheral Stent System; Protégé™ RX Self-Expanding Carotid Stent System
Applicant: Medtronic Vascular, Inc.
PMA number: P060001
Supplement: S059
Product code: NIM
Generic name: Stent, carotid
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