FDA PMA

Sealant, dural

Número do PMA: P240027 · 2026-09-11

RequerentePramand, LLC

Data da decisão2026-09-11

Número PMAP240027

Código do produtoNQR

Classe do DispositivoClasse 3

Especialidade MédicaU

Comité consultivoNE

Resumo do dispositivo

Sealant, dural is the device name listed in this FDA 510(k) record. The listed applicant is Pramand, LLC. It received FDA 510(k) clearance on 2026-09-11. The device is classified under product code NQR. It was reviewed by the NE advisory panel.

Perguntas frequentes

What is the Sealant, dural?

Sealant, dural is a medical device that received FDA 510(k) clearance on 2026-09-11. The listed applicant is Pramand, LLC.

When did Sealant, dural receive FDA 510(k) clearance?

The clearance date for Sealant, dural can be found in the official FDA records.

Who is the listed applicant for Sealant, dural?

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

What is the FDA product code for Sealant, dural?

The FDA product code for Sealant, dural is NQR.

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Fonte oficial

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