SPACEOAR - COFEPRIS Registration 314C2020 SSA
Access comprehensive regulatory information for SPACEOAR (SPACEOAR) in the Mexico medical device market through Pure Global AI's free database. This Clase III medical device is registered under COFEPRIS analysis ID 314C2020 SSA and manufactured by BOSTON SCIENTIFIC DEMÉXICO, S.A. DE C.V.. The device was registered on March 11, 2020.
This page provides complete registration details including product type (V. SURGICAL AND HEALING MATERIALS), manufacturer information, and regulatory compliance data from the official Mexico COFEPRIS medical device database. Pure Global AI offers free access to Mexico's complete medical device registry with bilingual Spanish/English support, helping global MedTech companies navigate COFEPRIS regulations efficiently.
ELSISTEMASPACESOAR™ESTÁINDICADOPARASITUAR TEMPORALMENTE LA PARED RECTALANTERIORLEJOSDELAPRÓSTATADURANTELARADIOTERAPIAPARAELCÁNCERDEPRÓSTATAY, AL CREAR ESTE ESPACIO, EL SISTEMASPACESOAR™PERMITEREDUCIRLADOSISDERADIACIÓN ADMINISTRADA AL RECTOANTERIOR. TODOS LOS COMPONENTES DELSISTEMA ESTÁN INDICADOS PARA UN SOLO USO.
THE SPACESOAR SYSTEM IS INDICATED TO TEMPORARILY PARASITISE THE ANTERIOR RECTAL WALL AWAY FROM THE PROSTATE DURING RADIOTHERAPY FOR PROSTATE CANCER AND, BY CREATING THIS SPACE, THE SPACESOAR™™SYSTEM MAKES IT POSSIBLE TO REDUCE THE RADIATION DELIVERED TO THE ANTERIOR RECTUM. ALL SYSTEM COMPONENTS ARE SUITABLE FOR SINGLE USE ONLY.