SELUTION SLR 014 PTCA Drug-Eluting Balloon
MedAlliance, LLC · Drug-eluting percutaneous transluminal coronary angioplasty catheter · Cardiovascular
Open FDA's page for this record- PMA number
- P250041
- Applicant
- MedAlliance, LLC
- Street 1
- 4 Jenner
- Street 2
- Suite 190
- City
- Irvine
- State
- CA
- Zip
- 92618
- Generic name
- Drug-eluting percutaneous transluminal coronary angioplasty catheter
- Trade name
- SELUTION SLR 014 PTCA Drug-Eluting Balloon
- Product code
- OOB
- Advisory committee
- CV
- Advisory committee description
- Cardiovascular
- Expedited review flag
- N
- Date received
- 2025-10-29
- Decision date
- 2026-09-18
- Decision code
- APPR
- Ao 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).
- Harmonized identifiers (openFDA)
- Device name
- Drug-Eluting Percutaneous Transluminal Coronary Angioplasty Catheter
- Medical specialty description
- Unknown
- Device class
- 3
- Registration number
- 1225687, 2124215, 9681260, 3012102437, 2134265, 3005969022, 2030598, 3015190176
- FEI number
- 1000518731, 2124215, 3002095335, 3002806565, 3012102437, 3005969022, 3015190176, 3001451463