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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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DeviceSELUTION SLR™ 014 PTCA Drug-Eluting Balloon
Generic NameDrug-eluting percutaneous transluminal coronary angioplasty catheter
ApplicantMedAlliance, LLC
4 Jenner
Suite 190
Irvine, CA 92618
PMA NumberP250041
Date Received10/29/2025
Decision Date09/18/2026
Product Code OOB 
Advisory Committee Cardiovascular
Clinical TrialsNCT04280029
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
The SELUTION SLR™ 014 PTCA Drug-Eluting Balloon is intended to be used after appropriate vessel preparation in patients undergoing percutaneous coronary intervention (PCI) in coronary arteries 2.25 mm to 4.50 mm in diameter and lesions <= 26 mm in length for the purpose of improving myocardial perfusion when treating in-stent restenosis (ISR).
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
Labeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
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