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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 / June 2026 / P250055

PMA approved

AMDS Hybrid Prosthesis

Artivion, Inc. · Jun 26, 2026 · P250055

FDA approved the AMDS Hybrid Prosthesis from Artivion, Inc. on Jun 26, 2026 under P250055, an original premarket approval. The device falls under product code QSK, Hybrid Stent Graft, Thoracic Aortic Lesion Treatment as a Class 3 device. The review panel was Cardiovascular.

FDA logged the submission as received on Dec 29, 2025. The decision came 179 days later.

Artivion, Inc. has one other decision in the tracker over the last 12 months: K252059 (CryoValve SG Pulmonary Valve (SGPV10) CryoValve SG Pulmonary Valve and Conduit (SGPV00)).

Questions & Answers

What did FDA approve under P250055?

P250055 is the FDA PMA for AMDS Hybrid Prosthesis, submitted by Artivion, Inc.. FDA's decision date was Jun 26, 2026, under product code QSK (Hybrid Stent Graft, Thoracic Aortic Lesion Treatment).

Who makes the AMDS Hybrid Prosthesis?

Artivion, Inc., based in Kennesaw, GA, is the applicant of record for P250055.

How long did the P250055 review take?

FDA received the submission on Dec 29, 2025 and issued its decision on Jun 26, 2026, 179 days later.

← All decisions in June 2026