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FDA PMA

Drug-eluting percutaneous transluminal coronary angioplasty catheter

Número do PMA: P230035 · 2026-08-28

RequerenteBoston Scientific Corporation
Data da decisão2026-08-28
Número PMAP230035
Código do produtoOOB
Classe do DispositivoClasse 3
Especialidade MédicaU
Comité consultivoCV

Resumo do dispositivo

Drug-eluting percutaneous transluminal coronary angioplasty catheter is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific Corporation. It received FDA 510(k) clearance on 2026-08-28. The device is classified under product code OOB. It was reviewed by the CV advisory panel.

Perguntas frequentes

What is the Drug-eluting percutaneous transluminal coronary angioplasty catheter?

Drug-eluting percutaneous transluminal coronary angioplasty catheter is a medical device that received FDA 510(k) clearance on 2026-08-28. The listed applicant is Boston Scientific Corporation.

When did Drug-eluting percutaneous transluminal coronary angioplasty catheter receive FDA 510(k) clearance?

The clearance date for Drug-eluting percutaneous transluminal coronary angioplasty catheter can be found in the official FDA records.

Who is the listed applicant for Drug-eluting percutaneous transluminal coronary angioplasty catheter?

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

What is the FDA product code for Drug-eluting percutaneous transluminal coronary angioplasty catheter?

The FDA product code for Drug-eluting percutaneous transluminal coronary angioplasty catheter is OOB.

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Fonte oficial

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