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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 / December 2025 / P250011

PMA approved

ProVee System for BPH

Proverum, Ltd. · Dec 9, 2025 · P250011 · In the directory

FDA approved the ProVee System for BPH from Proverum, Ltd. on Dec 9, 2025 under P250011, an original premarket approval. The device falls under product code MER, Stent, Urethral, Prostatic, Permanent Or Semi-Permanent as a Class 3 device. The review panel was Gastroenterology, Urology.

FDA logged the submission as received on Apr 2, 2025. The decision came 251 days later.

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

Questions & Answers

What did FDA approve under P250011?

P250011 is the FDA PMA for ProVee System for BPH, submitted by Proverum, Ltd.. FDA's decision date was Dec 9, 2025, under product code MER (Stent, Urethral, Prostatic, Permanent Or Semi-Permanent).

Who makes the ProVee System for BPH?

Proverum, Ltd., based in Dublin, is the applicant of record for P250011. The company is listed in the MedDevice Startups directory.

How long did the P250011 review take?

FDA received the submission on Apr 2, 2025 and issued its decision on Dec 9, 2025, 251 days later.

← All decisions in December 2025