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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 / P250019

PMA approved

SAPIEN M3 Transcatheter Mitral Valve Replacement System

Edwards Lifesciences, LLC · Dec 22, 2025 · P250019

FDA approved the SAPIEN M3 Transcatheter Mitral Valve Replacement System from Edwards Lifesciences, LLC on Dec 22, 2025 under P250019, an original premarket approval. The device falls under product code NPU, Prosthesis, Mitral Valve, Percutaneously Delivered as a Class 3 device. The review panel was Cardiovascular.

FDA logged the submission as received on Jun 25, 2025. The decision came 180 days later.

Edwards Lifesciences, LLC has 8 other decisions in the tracker over the last 12 months: K254232 (ECLIPTIS Left Atrial Appendage Exclusion System (ECS135); ECLIPTIS Left Atrial Appendage Exclusion System (ECS140); ECLIPTIS Left Atrial Appendage Exclusion System (ECS145); ECLIPTIS Left Atrial Appendage Exclusion System (ECS150)), K251326 (Respiration Rate algorithm), K260105 (Fogarty Spring Clips, Handleless Clamps, and Clamp Inserts), K254279 (Edwards eSheath+ introducer set).

Questions & Answers

What did FDA approve under P250019?

P250019 is the FDA PMA for SAPIEN M3 Transcatheter Mitral Valve Replacement System, submitted by Edwards Lifesciences, LLC. FDA's decision date was Dec 22, 2025, under product code NPU (Prosthesis, Mitral Valve, Percutaneously Delivered).

Who makes the SAPIEN M3 Transcatheter Mitral Valve Replacement System?

Edwards Lifesciences, LLC, based in Irvine, CA, is the applicant of record for P250019.

How long did the P250019 review take?

FDA received the submission on Jun 25, 2025 and issued its decision on Dec 22, 2025, 180 days later.

← All decisions in December 2025