Ranger Paclitaxel-Coated PTA Balloon Catheter
FDA premarket approval P190019/S038 · decided 2025-06-26
Approval details
- PMA number
- P190019
- Supplement
- S038
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Ranger Paclitaxel-Coated PTA Balloon Catheter
- Generic name
- Drug-Eluting Peripheral Transluminal Angioplasty Catheter
- Applicant
- Boston Scientific Corporation
- Date received
- 2025-03-21
- Decision date
- 2025-06-26
- Days to decision
- 97 days
- Decision code
- APPR
- Product code
- ONU
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Maple Grove, MN
- Statement
- the addition of another manufacturing building and cleanroom at the same contract manufacturer facility to accommodate additional future drug coating lines
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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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| MOSES Raydar™ (K260100) | Boston Scientific Corporation | 2026-05-18 |
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