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FDA PMA

Automated insulin dosing device system, single hormonal control

PMA Number: P160017 · 2026-09-29

ApplicantMedtronic Minimed, Inc.
Decision Date2026-09-29
PMA NumberP160017
Product CodeOZP
Device ClassClass 3
Medical SpecialtyU
Advisory CommitteeCH

Device Summary

Automated insulin dosing device system, single hormonal control is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Minimed, Inc.. It received FDA 510(k) clearance on 2026-09-29. The device is classified under product code OZP. It was reviewed by the CH advisory panel.

Frequently Asked Questions

What is the Automated insulin dosing device system, single hormonal control?

Automated insulin dosing device system, single hormonal control is a medical device that received FDA 510(k) clearance on 2026-09-29. The listed applicant is Medtronic Minimed, Inc..

When did Automated insulin dosing device system, single hormonal control receive FDA 510(k) clearance?

The clearance date for Automated insulin dosing device system, single hormonal control can be found in the official FDA records.

Who is the listed applicant for Automated insulin dosing device system, single hormonal control?

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

What is the FDA product code for Automated insulin dosing device system, single hormonal control?

The FDA product code for Automated insulin dosing device system, single hormonal control is OZP.

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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