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FDA PMA

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

Número do PMA: P880006 · 2016-02-12

RequerenteSt. Jude Medical, Inc.
Data da decisão2016-02-12
Número PMAP880006
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 St. Jude Medical, Inc.. It received FDA 510(k) clearance on 2016-02-12. 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 2016-02-12. The listed applicant is St. Jude Medical, Inc..

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 St. Jude Medical, Inc. 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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