Peripheral stents
Protégé GPS
by EV3, Inc
A non-bioabsorbable tubular device intended to be implanted in a peripheral artery (excludes aorta, coronary, pulmonary, and intracranial arteries) to indefinitely maintain patency and improve luminal diameter in patients with atherosclerotic disease, or following the recanalization of a total occlusion. It may additionally be intended to be implanted in an obstructed biliary duct; it is not dedicated to carotid artery implantation, and not intended for connection with an aortic stent. It is made entirely of metal [e.g., Nitinol alloy mesh structure] and typically implanted by a dedicated instrument where it self-expands upon release or is balloon expanded.
Protégé GPS models and sizes
From the FDA Global Unique Device Identification Database. Confirm with the manufacturer's instructions for use.
| Model / catalog no. | Size | MRI | Status |
|---|---|---|---|
| SERB65-09-20-80 | Catheter Gauge 6.0 Fr; Length 20.0 mm | MR Conditional | Available |
| SERB65-09-20-80 | Catheter Gauge 6.0 Fr; Length 20.0 mm | MR Conditional | Available |
| SERB65-09-20-120 | Length 20.0 mm; Catheter Gauge 6.0 Fr | MR Conditional | Available |
| SERB65-09-20-120 | Catheter Gauge 6.0 Fr; Length 20.0 mm | MR Conditional | Available |
| SERB65-09-30-80 | Catheter Gauge 6.0 Fr; Length 30.0 mm | MR Conditional | Available |
| SERB65-09-30-80 | Length 30.0 mm; Catheter Gauge 6.0 Fr | MR Conditional | Available |
| SERB65-09-30-120 | Length 30.0 mm; Catheter Gauge 6.0 Fr | MR Conditional | Available |
| SERB65-09-30-120 | Length 30.0 mm; Catheter Gauge 6.0 Fr | MR Conditional | Available |
| SERB65-09-40-80 | Catheter Gauge 6.0 Fr; Length 40.0 mm | MR Conditional | Available |
| SERB65-09-40-80 | Length 40.0 mm; Catheter Gauge 6.0 Fr | MR Conditional | Available |
| SERB65-09-40-120 | Catheter Gauge 6.0 Fr; Length 40.0 mm | MR Conditional | Available |
| SERB65-09-40-120 | Length 40.0 mm; Catheter Gauge 6.0 Fr | MR Conditional | Available |
| SERB65-09-60-80 | Length 60.0 mm; Catheter Gauge 6.0 Fr | MR Conditional | Available |
| SERB65-09-60-80 | Catheter Gauge 6.0 Fr; Length 60.0 mm | MR Conditional | Available |
| SERB65-09-60-120 | Catheter Gauge 6.0 Fr; Length 60.0 mm | MR Conditional | Available |
| SERB65-09-60-120 | Length 60.0 mm; Catheter Gauge 6.0 Fr | MR Conditional | Available |
| SERB65-09-80-80 | Length 80.0 mm; Catheter Gauge 6.0 Fr | MR Conditional | Available |
| SERB65-09-80-80 | Length 80.0 mm; Catheter Gauge 6.0 Fr | MR Conditional | Available |
| SERB65-09-80-120 | Catheter Gauge 6.0 Fr; Length 80.0 mm | MR Conditional | Available |
| SERB65-09-80-120 | Catheter Gauge 6.0 Fr; Length 80.0 mm | MR Conditional | Available |
| SERB65-10-20-80 | Catheter Gauge 6.0 Fr; Length 20.0 mm | MR Conditional | Available |
| SERB65-10-20-80 | Length 20.0 mm; Catheter Gauge 6.0 Fr | MR Conditional | Available |
| SERB65-10-20-120 | Length 20.0 mm; Catheter Gauge 6.0 Fr | MR Conditional | Available |
| SERB65-10-20-120 | Catheter Gauge 6.0 Fr; Length 20.0 mm | MR Conditional | Available |
| SERB65-10-30-80 | Length 30.0 mm; Catheter Gauge 6.0 Fr | MR Conditional | Available |
| SERB65-10-30-80 | Length 30.0 mm; Catheter Gauge 6.0 Fr | MR Conditional | Available |
| SERB65-10-30-120 | Length 30.0 mm; Catheter Gauge 6.0 Fr | MR Conditional | Available |
| SERB65-10-30-120 | Catheter Gauge 6.0 Fr; Length 30.0 mm | MR Conditional | Available |
| SERB65-10-40-80 | Catheter Gauge 6.0 Fr; Length 40.0 mm | MR Conditional | Available |
| SERB65-10-40-80 | Catheter Gauge 6.0 Fr; Length 40.0 mm | MR Conditional | Available |
| SERB65-10-40-120 | Length 40.0 mm; Catheter Gauge 6.0 Fr | MR Conditional | Available |
| SERB65-10-40-120 | Catheter Gauge 6.0 Fr; Length 40.0 mm | MR Conditional | Available |
| SERB65-10-60-80 | Catheter Gauge 6.0 Fr; Length 60.0 mm | MR Conditional | Available |
| SERB65-10-60-80 | Catheter Gauge 6.0 Fr; Length 60.0 mm | MR Conditional | Available |
| SERB65-10-60-120 | Catheter Gauge 6.0 Fr; Length 60.0 mm | MR Conditional | Available |
| SERB65-10-60-120 | Length 60.0 mm; Catheter Gauge 6.0 Fr | MR Conditional | Available |
| SERB65-10-80-80 | Length 80.0 mm; Catheter Gauge 6.0 Fr | MR Conditional | Available |
| SERB65-10-80-80 | Length 80.0 mm; Catheter Gauge 6.0 Fr | MR Conditional | Available |
| SERB65-10-80-120 | Length 80.0 mm; Catheter Gauge 6.0 Fr | MR Conditional | Available |
| SERB65-10-80-120 | Catheter Gauge 6.0 Fr; Length 80.0 mm | MR Conditional | Available |
| SERB65-12-20-80 | Catheter Gauge 6.0 Fr; Length 20.0 mm | MR Conditional | Available |
| SERB65-12-20-80 | Length 20.0 mm; Catheter Gauge 6.0 Fr | MR Conditional | Available |
| SERB65-12-20-120 | Length 20.0 mm; Catheter Gauge 6.0 Fr | MR Conditional | Available |
| SERB65-12-20-120 | Catheter Gauge 6.0 Fr; Length 20.0 mm | MR Conditional | Available |
| SERB65-12-30-80 | Catheter Gauge 6.0 Fr; Length 30.0 mm | MR Conditional | Available |
| SERB65-12-30-80 | Catheter Gauge 6.0 Fr; Length 30.0 mm | MR Conditional | Available |
| SERB65-12-30-120 | Catheter Gauge 6.0 Fr; Length 30.0 mm | MR Conditional | Available |
| SERB65-12-30-120 | Catheter Gauge 6.0 Fr; Length 30.0 mm | MR Conditional | Available |
| SERB65-12-40-80 | Catheter Gauge 6.0 Fr; Length 40.0 mm | MR Conditional | Available |
| SERB65-12-40-80 | Catheter Gauge 6.0 Fr; Length 40.0 mm | MR Conditional | Available |
| SERB65-12-40-120 | Catheter Gauge 6.0 Fr; Length 40.0 mm | MR Conditional | Available |
| SERB65-12-40-120 | Length 40.0 mm; Catheter Gauge 6.0 Fr | MR Conditional | Available |
| SERB65-12-60-80 | Catheter Gauge 6.0 Fr; Length 60.0 mm | MR Conditional | Available |
| SERB65-12-60-80 | Length 60.0 mm; Catheter Gauge 6.0 Fr | MR Conditional | Available |
| SERB65-12-60-120 | Catheter Gauge 6.0 Fr; Length 60.0 mm | MR Conditional | Available |
| SERB65-12-60-120 | Length 60.0 mm; Catheter Gauge 6.0 Fr | MR Conditional | Available |
| SERB65-12-80-80 | Length 80.0 mm; Catheter Gauge 6.0 Fr | MR Conditional | Available |
| SERB65-12-80-80 | Length 80.0 mm; Catheter Gauge 6.0 Fr | MR Conditional | Available |
| SERB65-12-80-120 | Length 80.0 mm; Catheter Gauge 6.0 Fr | MR Conditional | Available |
| SERB65-12-80-120 | Catheter Gauge 6.0 Fr; Length 80.0 mm | MR Conditional | Available |
| SERB65-14-20-80 | Catheter Gauge 6.0 Fr; Length 20.0 mm | MR Conditional | Available |
| SERB65-14-20-120 | Length 20.0 mm; Catheter Gauge 6.0 Fr | MR Conditional | Available |
| SERB65-14-30-80 | Catheter Gauge 6.0 Fr; Length 30.0 mm | MR Conditional | Available |
| SERB65-14-30-120 | Catheter Gauge 6.0 Fr; Length 30.0 mm | MR Conditional | Available |
| SERB65-14-40-80 | Catheter Gauge 6.0 Fr; Length 40.0 mm | MR Conditional | Available |
| SERB65-14-40-120 | Length 40.0 mm; Catheter Gauge 6.0 Fr | MR Conditional | Available |
| SERB65-14-60-80 | Catheter Gauge 6.0 Fr; Length 60.0 mm | MR Conditional | Available |
| SERB65-14-60-120 | Length 60.0 mm; Catheter Gauge 6.0 Fr | MR Conditional | Available |
| SERB65-14-80-80 | Length 80.0 mm; Catheter Gauge 6.0 Fr | MR Conditional | Available |
| SERB65-14-80-120 | Length 80.0 mm; Catheter Gauge 6.0 Fr | MR Conditional | Available |
FDA clearances
- PMA P060001 July 2024
Procedures that use peripheral stents
Frequently asked questions
What is Protégé GPS used for?
A non-bioabsorbable tubular device intended to be implanted in a peripheral artery (excludes aorta, coronary, pulmonary, and intracranial arteries) to indefinitely maintain patency and improve luminal diameter in patients with atherosclerotic disease, or following the recanalization of a total occlusion. It may additionally be intended to be implanted in an obstructed biliary duct; it is not dedicated to carotid artery implantation, and not intended for connection with an aortic stent. It is made entirely of metal [e.g., Nitinol alloy mesh structure] and typically implanted by a dedicated instrument where it self-expands upon release or is balloon expanded.
Who makes Protégé GPS?
Protégé GPS is made by EV3, Inc. It is listed under peripheral artery stents and covered stents, biliary drainage catheters in our device library.
What sizes does Protégé GPS come in?
Sizes listed for Protégé GPS: Length: 20–80 mm; Catheter Gauge: 6 Fr. Confirm availability with the manufacturer's instructions for use.
Is Protégé GPS MRI safe?
The FDA device database lists Protégé GPS as MR Conditional. Always follow the specific MRI conditions in the labeling.
Is Protégé GPS FDA cleared?
Protégé GPS is covered by FDA submission P060001.
How do I contact a EV3, Inc sales representative?
EV3, Inc has not listed representatives on LA Vascular yet. Visit the EV3, Inc company page for contact details.
Models, sizes and MRI status come from the FDA Global Unique Device Identification Database (GUDID); descriptions marked "provided by the manufacturer" are reviewed before publishing. Not an endorsement; follow the manufacturer's instructions for use.