ELECTRODOS DIRECCIONALESDBS - COFEPRIS Registration 65C2020 SSA
Access comprehensive regulatory information for ELECTRODOS DIRECCIONALESDBS (DIRECTIONAL ELECTRODESDBS) in the Mexico medical device market through Pure Global AI's free database. This Clase III medical device is registered under COFEPRIS analysis ID 65C2020 SSA and manufactured by BOSTON SCIENTIFIC DEMÉXICO, S.A. DE C.V.. The device was registered on February 04, 2020.
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.
ELECTRODOS DIRECCIONALES DBS ESTÁNINDICADOSPARASUUSOENCONJUNTOCONLA FAMILIA VERCISE PARA: ESTIMULACIÓNUNILATERAL O BILATERAL DEL NÚCLEOSUBTALÁMICO(STN)OGLOBOPÁLIDOINTERNO(GPI) PARA ENFERMEDAD DE PARKINSONRESPONSIVA A LEVODOPA NO CONTROLADAADECUADAMENTE CON MEDICACIÓN.ESTIMULACIÓN UNILATERAL O BILATERAL DELNÚCLEOSUBTALÁMICO(STN)OGLOBOPÁLIDOINTERNO (GPI) PARA DISTONIA PRIMARIA YSECUNDARIA INTRATABLE, PARA PERSONAS APARTIR DE 7 AÑOS.
DBS DIRECTIONAL ELECTRODES ARE INDICATED FOR USE IN CONJUNCTION WITH THE VERCISE FAMILY FOR: UNILATERAL OR BILATERAL STIMULATION OF THE SUBTHALAMIC NUCLEUS (STN) OR INTERNAL GLOBULOID NUCLEUS (PG) FOR PARKINSONRESPONSIVE DISEASE TO LEVODOPA NOT ADEQUATELY CONTROLLED WITH MEDICATION. UNILATERAL OR BILATERAL STIMULATION OF THE SUBTHALAMIC NUCLEUS (STN) OR INTERNAL GLOBOPALLID NUCLEUS (PG) FOR PRIMARY AND SECONDARY INTRACTABLE DYSTONIA, FOR PEOPLE AGED 7 YEARS AND OLDER.