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FDA PMA

Automated insulin dosing , threshold suspend

PMA Number: P120010 · 2026-07-21

ApplicantMedtronic, Inc.
Decision Date2026-07-21
PMA NumberP120010
Product CodeOZO
Device ClassClass 3
Medical SpecialtyU
Advisory CommitteeCH

Device Summary

Automated insulin dosing , threshold suspend is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic, Inc.. It received FDA 510(k) clearance on 2026-07-21. The device is classified under product code OZO. It was reviewed by the CH advisory panel.

Frequently Asked Questions

What is the Automated insulin dosing , threshold suspend?

Automated insulin dosing , threshold suspend is a medical device that received FDA 510(k) clearance on 2026-07-21. The listed applicant is Medtronic, Inc..

When did Automated insulin dosing , threshold suspend receive FDA 510(k) clearance?

The clearance date for Automated insulin dosing , threshold suspend can be found in the official FDA records.

Who is the listed applicant for Automated insulin dosing , threshold suspend?

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

What is the FDA product code for Automated insulin dosing , threshold suspend?

The FDA product code for Automated insulin dosing , threshold suspend is OZO.

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

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

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