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PMA de la FDA

Implanted fecal incontinence device

Número de PMA: P010020 · 2016-02-04

SolicitanteBoston Scientific Corp
Fecha de decisión2016-02-04
Número PMAP010020
Código de productoMIP
Clase del dispositivoClase 3
Especialidad médicaU
Comité asesorGU

Resumen del dispositivo

Implanted fecal incontinence device is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific Corp. It received FDA 510(k) clearance on 2016-02-04. The device is classified under product code MIP. It was reviewed by the GU advisory panel.

Preguntas frecuentes

What is the Implanted fecal incontinence device?

Implanted fecal incontinence device is a medical device that received FDA 510(k) clearance on 2016-02-04. The listed applicant is Boston Scientific Corp.

When did Implanted fecal incontinence device receive FDA 510(k) clearance?

The clearance date for Implanted fecal incontinence device can be found in the official FDA records.

Who is the listed applicant for Implanted fecal incontinence device?

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

What is the FDA product code for Implanted fecal incontinence device?

The FDA product code for Implanted fecal incontinence device is MIP.

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Fuente oficial

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