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FDA PMA

Automated insulin dosing device system, single hormonal control

Número do PMA: P160017 · 2026-08-05

RequerenteMedtronic Minimed, Inc.
Data da decisão2026-08-05
Número PMAP160017
Código do produtoOZP
Classe do DispositivoClasse 3
Especialidade MédicaU
Comité consultivoCH

Resumo do dispositivo

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 2026-08-05. The device is classified under product code OZP. It was reviewed by the CH advisory panel.

Perguntas frequentes

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 2026-08-05. 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.

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Fonte oficial

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