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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 / 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.

This is the only decision on file for Artivion, Inc. in the last 12 months of the tracker.

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