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Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets

The Tracker / October 2026 / P260007

PMA approved

Autus Size-Adjustable Valve

Edwards Lifesciences, LLC · Oct 1, 2026 · P260007

FDA approved the Autus Size-Adjustable Valve from Edwards Lifesciences, LLC on Oct 1, 2026 under P260007, an original premarket approval. The device falls under product code SJL, Heart-Valve, Polymeric as a Class 3 device. The review panel was Cardiovascular.

FDA logged the submission as received on Feb 9, 2026. The decision came 234 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 P260007?

P260007 is the FDA PMA for Autus Size-Adjustable Valve, submitted by Edwards Lifesciences, LLC. FDA's decision date was Oct 1, 2026, under product code SJL (Heart-Valve, Polymeric).

Who makes the Autus Size-Adjustable Valve?

Edwards Lifesciences, LLC, based in Irvine, CA, is the applicant of record for P260007.

How long did the P260007 review take?

FDA received the submission on Feb 9, 2026 and issued its decision on Oct 1, 2026, 234 days later.

← All decisions in October 2026