FDA PMA

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

Номер PMA: P010031 · 2026-09-25

ЗаявительMedtronic Cardiac Rhythm Disease Management

Дата решения2026-09-25

Номер PMAP010031

Код продуктаNIK

Класс устройстваКласс 3

Медицинская специализацияU

Консультативный комитетCV

Описание устройства

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.

Часто задаваемые вопросы

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.

Связанные клинические исследования

Связанные записи сопоставляются автоматически на основании названий, кодов продукции или иных метаданных. Сопоставление не подтверждает клиническую, научную, корпоративную или регуляторную связь; ознакомьтесь с официальными источниками по ссылкам.

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Официальный источник

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