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FDA PMA

implantable pacemaker Pulse-generator

Número do PMA: P950037 · 2026-09-25

RequerenteBiotronik, Inc.
Data da decisão2026-09-25
Número PMAP950037
Código do produtoDXY
Classe do DispositivoClasse 3
Especialidade MédicaC
Número da Regulamentação21 CFR 8
Comité consultivoCV

Resumo do dispositivo

implantable pacemaker Pulse-generator is the device name listed in this FDA 510(k) record. The listed applicant is Biotronik, Inc.. It received FDA 510(k) clearance on 2026-09-25. The device is classified under product code DXY. It was reviewed by the CV advisory panel. Product code DXY falls under the category of Clinical Chemistry, which covers reagents and instruments for chemical analysis of clinical samples. Devices in this category are subject to specific FDA regulatory requirements.

Perguntas frequentes

What is the implantable pacemaker Pulse-generator?

implantable pacemaker Pulse-generator is a medical device that received FDA 510(k) clearance on 2026-09-25. The listed applicant is Biotronik, Inc..

When did implantable pacemaker Pulse-generator receive FDA 510(k) clearance?

The clearance date for implantable pacemaker Pulse-generator can be found in the official FDA records.

Who is the listed applicant for implantable pacemaker Pulse-generator?

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

What is the FDA product code for implantable pacemaker Pulse-generator?

The FDA product code for implantable pacemaker Pulse-generator is DXY. This falls under the Clinical Chemistry category.

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