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Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / December 2025 / P250017

PMA approved

GORE® VIABAHN® FORTEGRA Venous Stent

W. L. Gore & Associates, Inc. · Dec 19, 2025 · P250017

FDA approved the GORE® VIABAHN® FORTEGRA Venous Stent from W. L. Gore & Associates, Inc. on Dec 19, 2025 under P250017, an original premarket approval. The review panel was Cardiovascular.

FDA logged the submission as received on Jun 20, 2025. The decision came 182 days later.

This is the only decision on file for W. L. Gore & Associates, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA approve under P250017?

P250017 is the FDA PMA for GORE® VIABAHN® FORTEGRA Venous Stent, submitted by W. L. Gore & Associates, Inc.. FDA's decision date was Dec 19, 2025, under product code QTL.

Who makes the GORE® VIABAHN® FORTEGRA Venous Stent?

W. L. Gore & Associates, Inc., based in Flagstaff, AZ, is the applicant of record for P250017.

How long did the P250017 review take?

FDA received the submission on Jun 20, 2025 and issued its decision on Dec 19, 2025, 182 days later.

← All decisions in December 2025