WALLSTENT (TIPS, ILIAC, VENOUS) ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEMS
FDA premarket approval P980033/S002 · decided 2002-05-10
Approval details
- PMA number
- P980033
- Supplement
- S002
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Express GMP Supplement
- Trade name
- WALLSTENT (TIPS, ILIAC, VENOUS) ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEMS
- Generic name
- Stent, central venous
- Applicant
- Boston Scientific Corporation
- Date received
- 2002-04-24
- Decision date
- 2002-05-10
- Days to decision
- 16 days
- Decision code
- APPR
- Product code
- QKJ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Maple Grove, MN
- Statement
- APPROVAL FOR AN ALTERNATE MANUFACTURING FACILITY FOR THE STENT COMPONENT OF THE WALLSTENT. PRODUCTS LOCATED AT BOSTON SCIENTIFIC IRELAND LTD. (BSIL), GALWAY, IRELAND.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| TheraSphere 360™ Y-90 Management Platform (K262462) | Boston Scientific Corporation | 2026-07-24 |
| FARADRIVE™ Steerable Sheath (M004PF21M402) (K262165) | Boston Scientific Corporation | 2026-07-24 |
| 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 |