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FDA PMA

diaphragmatic/phrenic nerve laparoscopically-implanted stimulator

Número do PMA: P200018 · 2023-03-31

RequerenteSynapse Biomedical, Inc.
Data da decisão2023-03-31
Número PMAP200018
Código do produtoOIR
Classe do DispositivoClasse 3
Especialidade MédicaU
Comité consultivoAN

Resumo do dispositivo

diaphragmatic/phrenic nerve laparoscopically-implanted stimulator is the device name listed in this FDA 510(k) record. The listed applicant is Synapse Biomedical, Inc.. It received FDA 510(k) clearance on 2023-03-31. The device is classified under product code OIR. It was reviewed by the AN advisory panel.

Perguntas frequentes

What is the diaphragmatic/phrenic nerve laparoscopically-implanted stimulator?

diaphragmatic/phrenic nerve laparoscopically-implanted stimulator is a medical device that received FDA 510(k) clearance on 2023-03-31. The listed applicant is Synapse Biomedical, Inc..

When did diaphragmatic/phrenic nerve laparoscopically-implanted stimulator receive FDA 510(k) clearance?

The clearance date for diaphragmatic/phrenic nerve laparoscopically-implanted stimulator can be found in the official FDA records.

Who is the listed applicant for diaphragmatic/phrenic nerve laparoscopically-implanted stimulator?

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

What is the FDA product code for diaphragmatic/phrenic nerve laparoscopically-implanted stimulator?

The FDA product code for diaphragmatic/phrenic nerve laparoscopically-implanted stimulator is OIR.

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Fonte oficial

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