# P060001: Protege GPS and Protege RX Carotid Stent Systems

- Pathway: PMA
- Applicant: Medtronic Vascular, Inc.
- Decided: Jan 24, 2007 after 380 days
- Product code: NIM (Stent, Carotid)
- Device class: 3
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. PMA decisions do not claim a predicate device.

## Recalls of this device
- Dec 4, 2014 · Class II · Z-0878-2015: Two production lots of the Protege Rx Tapered Carotid Stent Systems (SECX-10-7-40-135, Lot # 9922452 & SEPX-8-6-40-135, Lot # 9922795) because of a product labeling error.
- Dec 4, 2014 · Class II · Z-0879-2015: Two production lots of the Protege Rx Tapered Carotid Stent Systems (SECX-10-7-40-135, Lot # 9922452 & SEPX-8-6-40-135, Lot # 9922795) because of a product labeling error.

Source page: https://510kreport.com/device/P060001
Methodology: https://510kreport.com/methodology