Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 a medical device manufactured by Sirtex Medical, Inc.. It received FDA Premarket Approval (PMA) on 2026-05-07 under PMA number P990065. The device is classified under FDA product code NAW. It was reviewed by the RA advisory panel. This device is classified as Class III by the FDA. Class III devices subject to the most stringent regulatory controls. These devices generally require premarket approval (PMA) because they support or sustain human life, are of substantial importance in preventing impairment of human health, or present a potential unreasonable risk of illness or injury. PMA is the most stringent type of device marketing application required by the FDA. The device falls under the medical specialty of U. Unlike 510(k) clearance, which demonstrates substantial equivalence to a predicate device, PMA requires the manufacturer to submit clinical trial data demonstrating the safety and effectiveness of the device. PMA is generally required for Class III devices that support or sustain human life, are of substantial importance in preventing impairment of human health, or present a potential unreasonable risk of illness or injury.

Frequently Asked Questions

What is Microspheres radionuclide?

Microspheres radionuclide is a medical device that received FDA Premarket Approval (PMA) on 2026-05-07. It is manufactured by Sirtex Medical, Inc.. The PMA number is P990065.

When did Microspheres radionuclide receive FDA PMA approval?

Microspheres radionuclide received FDA PMA approval on 2026-05-07, under approval number P990065.

What company makes Microspheres radionuclide?

Microspheres radionuclide is manufactured by Sirtex Medical, Inc..

What is the difference between PMA and 510(k)?

PMA (Premarket Approval) is the FDA process for evaluating Class III medical devices. Unlike 510(k) clearance, which demonstrates substantial equivalence to a predicate device, PMA requires the manufacturer to provide clinical data proving safety and effectiveness. PMA is the most stringent type of device marketing application required by the FDA.

What is the FDA product code for Microspheres radionuclide?

The FDA product code for Microspheres radionuclide is NAW.

What FDA device class is Microspheres radionuclide?

Microspheres radionuclide is classified as Class III by the FDA.

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.

↑