Wallstent Venous Endoprosthesis with Unistep Plus Delivery System
FDA premarket approval P980033/S066 · decided 2024-06-27
Approval details
- PMA number
- P980033
- Supplement
- S066
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Wallstent Venous Endoprosthesis with Unistep Plus Delivery System
- Generic name
- Stent, central venous
- Applicant
- Boston Scientific Corporation
- Date received
- 2024-06-11
- Decision date
- 2024-06-27
- Days to decision
- 16 days
- Decision code
- OK30
- Product code
- QKJ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Maple Grove, MN
- Statement
- a new automated cleaning system at your component supplier
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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 |
| RIVOS™ EUS Access Device (M00553900) (K260428) | Boston Scientific Corporation | 2026-06-17 |
| 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 |