FDA PMA

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

Numéro PMA : P010012 · 2026-08-25

DemandeurBoston Scientific Corp

Date de décision2026-08-25

Numéro PMAP010012

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 Boston Scientific Corp. It received FDA 510(k) clearance on 2026-08-25. 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 2026-08-25. The listed applicant is Boston Scientific Corp.

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 Boston Scientific Corp 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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