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FDA PMA

Microspheres radionuclide

PMA Number: P990065 · 2026-05-07

ApplicantSirtex Medical, Inc.
Decision Date2026-05-07
PMA NumberP990065
Product CodeNAW
Device ClassClass 3
Medical SpecialtyU
Advisory CommitteeRA

Device Summary

Microspheres radionuclide is the device name listed in this FDA 510(k) record. The listed applicant is Sirtex Medical, Inc.. It received FDA 510(k) clearance on 2026-05-07. The device is classified under product code NAW. It was reviewed by the RA advisory panel.

Frequently Asked Questions

What is the Microspheres radionuclide?

Microspheres radionuclide is a medical device that received FDA 510(k) clearance on 2026-05-07. The listed applicant is Sirtex Medical, Inc..

When did Microspheres radionuclide receive FDA 510(k) clearance?

The clearance date for Microspheres radionuclide can be found in the official FDA records.

Who is the listed applicant for Microspheres radionuclide?

The FDA 510(k) record lists Sirtex Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Microspheres radionuclide?

The FDA product code for Microspheres radionuclide is NAW.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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