SISTEMA VALVULAR AÓRTICO ACURATE BOSTON SCIENTIFIC. - COFEPRIS Registration 2315C2018 SSA
Access comprehensive regulatory information for SISTEMA VALVULAR AÓRTICO ACURATE BOSTON SCIENTIFIC. (SISTEMA VALVULAR AÓRTICO ACURATE BOSTON SCIENTIFIC.) in the Mexico medical device market through Pure Global AI's free database. This Clase III medical device is registered under COFEPRIS analysis ID 2315C2018 SSA and manufactured by BOSTON SCIENTIFIC DE MÉXICO, S.A. DE C.V.. The device was registered on October 08, 2018.
This page provides complete registration details including product type (II. PROSTHETICS, ORTHOSES AND FUNCTIONAL AIDS), 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.
LA BIOPRÓTESIS AÓRTICA ACURATE NEO™ Y SU SISTEMA DE LIBERACIÓN ESTÁN INDICADOS PARA PACIENTES CON UNA EDAD IGUAL O SUPERIOR A LOS 75 AÑOS CON ESTENOSIS AÓRTICA SEVERA (GRADIENTE AÓRTICO MEDIO > 40 MMHG, PICO DE VELOCIDAD DEL JET > 4,0 M/S O ÁREA VALVULAR
THE ACURATE NEO™ AORTIC BIOPROSTHESIS AND ITS DELIVERY SYSTEM ARE INDICATED FOR PATIENTS AGED 75 YEARS OR OLDER WITH SEVERE AORTIC STENOSIS (MEAN AORTIC GRADIENT > 40 MMHG, PEAK JET VELOCITY > 4.0 M/S OR VALVULAR AREA