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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 / September 2025 / P240015

PMA approved

Womed Leaf Resorbable Adhesion Barrier

Womed Sas · Sep 9, 2025 · P240015 · In the directory

FDA approved the Womed Leaf Resorbable Adhesion Barrier from Womed Sas on Sep 9, 2025 under P240015, an original premarket approval. The device falls under product code MCN, Barrier, Absorbable, Adhesion as a Class 3 device. The review panel was Obstetrics/Gynecology.

FDA logged the submission as received on May 10, 2024. The decision came 487 days later.

This is the only decision on file for Womed Sas in the last 12 months of the tracker.

Questions & Answers

What did FDA approve under P240015?

P240015 is the FDA PMA for Womed Leaf Resorbable Adhesion Barrier, submitted by Womed Sas. FDA's decision date was Sep 9, 2025, under product code MCN (Barrier, Absorbable, Adhesion).

Who makes the Womed Leaf Resorbable Adhesion Barrier?

Womed Sas, based in Montpellier, is the applicant of record for P240015. The company is listed in the MedDevice Startups directory.

How long did the P240015 review take?

FDA received the submission on May 10, 2024 and issued its decision on Sep 9, 2025, 487 days later.

← All decisions in September 2025