AGENT Paclitaxel-Coated Balloon Catheter
FDA premarket approval P230035 · decided 2024-02-29
Approval details
- PMA number
- P230035
- Trade name
- AGENT Paclitaxel-Coated Balloon Catheter
- Generic name
- Drug-eluting percutaneous transluminal coronary angioplasty catheter
- Applicant
- Boston Scientific Corporation
- Date received
- 2023-10-05
- Decision date
- 2024-02-29
- Days to decision
- 147 days
- Decision code
- APPR
- Product code
- OOB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Maple Grove, MN
- Statement
- The AGENT Paclitaxel-Coated Balloon Catheter is intended to be used after appropriate vessel preperation in adult patients undergoing percutaneous coronary intervention (PCI) in coronary arteries 2.0 mm to 4.0 mm in diameter and lesions up to 26 mm in length for the purpose of improving myocardial perfusion when treating in-stent restenosis (ISR).
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510(k) clearances by this applicant
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|---|---|---|
| TheraSphere 360™ Y-90 Management Platform (K262462) | Boston Scientific Corporation | 2026-07-24 |
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| OBSIDIO Conformable Embolic (K261488) | Boston Scientific Corporation | 2026-07-24 |
| WallFlex Esophageal Stent System;Agile Esophageal Over-the-Wire (OTW) Stent System (K261978) | Boston Scientific Corporation | 2026-07-10 |
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| MOSES Raydar™ (K260100) | Boston Scientific Corporation | 2026-05-18 |
| TruSelect™ 2.6 Microcatheter (K260771) | Boston Scientific Corporation | 2026-05-15 |
| Asurys Fluid Management System (K251273) | Boston Scientific Corporation | 2026-03-27 |