ELECTRODOS DBS - COFEPRIS Registration 281C2020 SSA
Access comprehensive regulatory information for ELECTRODOS DBS (DBS ELECTRODES) in the Mexico medical device market through Pure Global AI's free database. This Clase III medical device is registered under COFEPRIS analysis ID 281C2020 SSA and manufactured by BOSTON SCIENTIFIC DEMÉXICO, S.A. DE C.V.. The device was registered on March 05, 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.
LOSELECTRODOSDBSESTÁNINDICADOSPARASU USO CON LOS ESTIMULADORES DE LAFAMILIA VERCISE PARA: ESTIMULACIÓNUNILATERAL O BILATERAL DEL NÚCLEOSUBTALÁMICO (STN) O GLOBUS PALLIDUSINTERNO (GPI) PARA LA ENFERMEDAD DEPARKINSONCONRESPUESTAALALEVODOPA,QUENOSECONTROLAADECUADAMENTECONMEDICACIÓN. ESTIMULACIÓN UNILATERAL OBILATERALDELNÚCLEOSUBTALÁMICO(STN)OGLOBUS PALLIDUS INTERNO (GPI) PARA LADISTONÍA PRIMARIA Y SECUNDARIA NOTRATABLE.
ELECTRODES ARE INDICATED FOR USE WITH STIMULATORS OF THE VERCISE FAMILY FOR: UNILATERAL OR BILATERAL STIMULATION OF THE SUBTHALAMIC NUCLEUS (STN) OR INTERNAL PALLIDUS GLOBUS (PG) FOR PARKIN DISEASE IN RESPONSE TO LEVODOPA, WHICH IS NOT ADEQUATELY CONTROLLED WITH MEDICATION. UNILATERAL OR BILATERAL STIMULATION OF THE SUBTHALAMIC NUCLEUS (STN) OR INTERNAL PALLIDUS GLOBUS (GPI) FOR NONTREATABLE PRIMARY AND SECONDARY DYSTONIA.