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The Tracker / September 2026 / P250041

PMA approved

SELUTION SLR 014 PTCA Drug-Eluting Balloon

MedAlliance, LLC · Sep 18, 2026 · P250041

FDA approved the SELUTION SLR 014 PTCA Drug-Eluting Balloon from MedAlliance, LLC on Sep 18, 2026 under P250041, an original premarket approval. The device falls under product code OOB, Drug-Eluting Percutaneous Transluminal Coronary Angioplasty Catheter as a Class 3 device. The review panel was Cardiovascular.

FDA logged the submission as received on Oct 29, 2025. The decision came 324 days later.

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

Questions & Answers

What did FDA approve under P250041?

P250041 is the FDA PMA for SELUTION SLR 014 PTCA Drug-Eluting Balloon, submitted by MedAlliance, LLC. FDA's decision date was Sep 18, 2026, under product code OOB (Drug-Eluting Percutaneous Transluminal Coronary Angioplasty Catheter).

Who makes the SELUTION SLR 014 PTCA Drug-Eluting Balloon?

MedAlliance, LLC, based in Irvine, CA, is the applicant of record for P250041.

How long did the P250041 review take?

FDA received the submission on Oct 29, 2025 and issued its decision on Sep 18, 2026, 324 days later.

← All decisions in September 2026