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FDA PMA

Pulse-generator, single chamber, sensor driven, implantable

Número do PMA: P970013 · 2026-07-21

RequerenteABBOTT MEDICAL
Data da decisão2026-07-21
Número PMAP970013
Código do produtoLWO
Classe do DispositivoClasse 3
Especialidade MédicaU
Comité consultivoCV

Resumo do dispositivo

Pulse-generator, single chamber, sensor driven, implantable is the device name listed in this FDA 510(k) record. The listed applicant is ABBOTT MEDICAL. It received FDA 510(k) clearance on 2026-07-21. The device is classified under product code LWO. It was reviewed by the CV advisory panel.

Perguntas frequentes

What is the Pulse-generator, single chamber, sensor driven, implantable?

Pulse-generator, single chamber, sensor driven, implantable is a medical device that received FDA 510(k) clearance on 2026-07-21. The listed applicant is ABBOTT MEDICAL.

When did Pulse-generator, single chamber, sensor driven, implantable receive FDA 510(k) clearance?

The clearance date for Pulse-generator, single chamber, sensor driven, implantable can be found in the official FDA records.

Who is the listed applicant for Pulse-generator, single chamber, sensor driven, implantable?

The FDA 510(k) record lists ABBOTT MEDICAL as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Pulse-generator, single chamber, sensor driven, implantable?

The FDA product code for Pulse-generator, single chamber, sensor driven, implantable is LWO.

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Fonte oficial

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