PMA P250041
- Device
- SELUTION SLR™ 014 PTCA Drug-Eluting Balloon
- Applicant
- MedAlliance, LLC
- PMA number
- P250041
- Product code
- OOB
- Decision date
- 2026-09-18
- Classification
- Cardiovascular
- Generic name
- Drug-eluting percutaneous transluminal coronary angioplasty catheter
- 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).
Current openFDA PMA Record#
- Device
- SELUTION SLR™ 014 PTCA Drug-Eluting Balloon
- Applicant
- MedAlliance, LLC
- PMA number
- P250041
- Product code
- OOB
- Generic name
- Drug-eluting percutaneous transluminal coronary angioplasty catheter
- Decision date
- 2026-09-18
- Decision code
- APPR
- Date received
- 2025-10-29
- 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