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FDA PMA

Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)

Número do PMA: P010031 · 2026-09-25

RequerenteMedtronic Cardiac Rhythm Disease Management
Data da decisão2026-09-25
Número PMAP010031
Código do produtoNIK
Classe do DispositivoClasse 3
Especialidade MédicaU
Comité consultivoCV

Resumo do dispositivo

Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D) is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Cardiac Rhythm Disease Management. It received FDA 510(k) clearance on 2026-09-25. The device is classified under product code NIK. It was reviewed by the CV advisory panel.

Perguntas frequentes

What is the Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)?

Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D) is a medical device that received FDA 510(k) clearance on 2026-09-25. The listed applicant is Medtronic Cardiac Rhythm Disease Management.

When did Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D) receive FDA 510(k) clearance?

The clearance date for Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D) can be found in the official FDA records.

Who is the listed applicant for Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)?

The FDA 510(k) record lists Medtronic Cardiac Rhythm Disease Management as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)?

The FDA product code for Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D) is NIK.

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