FDA PMA

Implantable cardioverter defibrillator (non-CRT)

Número do PMA: P980016 · 2026-09-25

RequerenteMedtronic Cardiac Rhythm Disease Management

Data da decisão2026-09-25

Número PMAP980016

Código do produtoLWS

Classe do DispositivoClasse 3

Especialidade MédicaU

Comité consultivoCV

Resumo do dispositivo

Implantable cardioverter defibrillator (non-CRT) 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 LWS. It was reviewed by the CV advisory panel.

Perguntas frequentes

What is the Implantable cardioverter defibrillator (non-CRT)?

Implantable cardioverter defibrillator (non-CRT) 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 Implantable cardioverter defibrillator (non-CRT) receive FDA 510(k) clearance?

The clearance date for Implantable cardioverter defibrillator (non-CRT) can be found in the official FDA records.

Who is the listed applicant for Implantable cardioverter defibrillator (non-CRT)?

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

Qual é o código de produto FDA para o Disjuntor Cardíaco Implantável (não-CRT)?

The FDA product code for Implantable cardioverter defibrillator (non-CRT) is LWS.

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Fonte oficial

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