FDA PMA

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

Numéro PMA : P880006 · 2016-02-12

DemandeurSt. Jude Medical, Inc.

Date de décision2016-02-12

Numéro PMAP880006

Code produitNIK

Classe de dispositifClasse 3

Spécialité médicaleU

Comité consultatifCV

Résumé du dispositif

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.

Questions fréquentes

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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Source officielle

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