# NAW · Microspheres Radionuclide

_ ·  · Class 3_

**Canonical URL:** https://fda-staging.innolitics.com/productcode/NAW

## Overview

- **Product Code:** NAW
- **Device Name:** Microspheres Radionuclide
- **Regulation:** 21 CFR N/A
- **Device Class:** 3
- **Review Panel:** [](/submissions/)
- **Implant:** yes

## Identification

Approved PMA:  P990065

## Recent Cleared Devices (4 of 4)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [P200029S011](/device/P200029S011.md) | TheraSphere | Boston Scientific Corporation | Feb 10, 2026 | APPR |
| [P990065S014](/device/P990065S014.md) | SIR-Spheres Y-90 resin microspheres | Sirtex Medical, Inc. | Jul 1, 2025 | APPR |
| [P200029](/device/P200029.md) | TheraSphere | Boston Scientific Corporation | Mar 17, 2021 | APPR |
| [P990065](/device/P990065.md) | SIR-SPHERES | Sirtex Medical, Inc. | Mar 5, 2002 | APPR |

## Top Applicants

- Boston Scientific Corporation — 2 clearances
- Sirtex Medical, Inc. — 2 clearances

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**Source:** [https://fda-staging.innolitics.com/productcode/NAW](https://fda-staging.innolitics.com/productcode/NAW)

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