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FDA PMA

Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)

Número do PMA: P070008 · 2026-09-25

RequerenteBiotronik, Inc.
Data da decisão2026-09-25
Número PMAP070008
Código do produtoNKE
Classe do DispositivoClasse 3
Especialidade MédicaU
Comité consultivoCV

Resumo do dispositivo

Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P) 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 NKE. It was reviewed by the CV advisory panel.

Perguntas frequentes

What is the Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)?

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

When did Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P) receive FDA 510(k) clearance?

The clearance date for Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P) can be found in the official FDA records.

Who is the listed applicant for Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)?

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 Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)?

The FDA product code for Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P) is NKE.

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Fonte oficial

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