SISTEMA DE STENT CORONARIO DE PLATINO-CROMO CON LIBERACIÓN DE EVEROLIMUS - INVIMA Registration 8d50044260ac1819913b10cec9c6642f
Access comprehensive regulatory information for SISTEMA DE STENT CORONARIO DE PLATINO-CROMO CON LIBERACIÓN DE EVEROLIMUS (PLATINUM-CHROMIUM CORONARY STENT SYSTEM WITH EVEROLIMUS RELEASE) in the Colombia medical device market through Pure Global AI's free database. This III medical device is registered under INVIMA analysis ID 8d50044260ac1819913b10cec9c6642f and manufactured by BOSTON SCIENTIFIC CORPORATION. The device was registered on August 25, 2033.
This page provides complete registration details including product type (SURGICAL DOCTOR), authorised information, and regulatory compliance data from the official Colombia INVIMA medical device database. Pure Global AI offers free access to Colombia's complete medical device registry with bilingual Spanish/English support, helping global MedTech companies navigate INVIMA regulations efficiently.
ESTÁ INDICADO PARA MEJORAR EL DIÁMETRO LUMINAL DEBIDO A ESTENOSIS DISCRETAS DE LAS ARTERIAS CORONARIAS NATIVAS DE NOVO EN PACIENTES CON CARDIOPATÍA ISQUÉMICA SINTOMÁTICA, INCLUIDOS AQUELLOS CON SÍNDROME CORONARIO AGUDO (INFARTO AGUDO DE MIOCARDIO Y ANGINA INESTABLE), DIABETES MELLITUS, INSUFICIENCIA RENAL O QUE TIENEN UN ALTO RIESGO DE HEMORRAGIA._x000D_ TAMBIÉN ESTÁ INDICADO PARA SU USO EN LOS SIGUIENTES TIPOS_x000D_ DE LESIONES CORONARIAS:_x000D_ O BIFURCACIÓN_x000D_ O LESIONES OSTIALES_x000D_ O ARTERIA CORONARIA PRINCIPAL IZQUIERDA SIN PROTECCIÓN_x000D_ O OCLUSIÓN TOTAL_x000D_ O RESTENOSIS EN EL STENT_x000D_ O INJERTO DE VENA SAFENA_x000D_ O ENFERMEDAD MULTIVASCULAR_x000D_ LA LONGITUD DE LA LESIÓN TRATADA DEBE SER INFERIOR A LA_x000D_ LONGITUD NOMINAL DEL STENT (8 MM, 12 MM,16 MM, 20 MM, 24 MM,_x000D_ 28 MM, 32 MM, 38 MM Y 48 MM*) CON UN DIÁMETRO VASCULAR DE_x000D_ REFERENCIA DE 2,25 MM A 5,00 MM**._x000D_ EL STENT DE 48 MM DE LONGITUD NO ESTÁ DISPONIBLE CON_x000D_ DIÁMETRO DE 2,25 MM._x000D_ LAS LONGITUDES DE 8 MM, 38 MM Y 48 MM NO ESTÁN DISPONIBLES_x000D_ EN LOS DIÁMETROS DE 4,50 MM Y 5,00 MM. _x000D_
IT IS INDICATED TO IMPROVE LUMINAL DIAMETER DUE TO DISCRETE STENOSES OF THE DE NOVO NATIVE CORONARY ARTERIES IN PATIENTS WITH SYMPTOMATIC ISCHEMIC HEART DISEASE, INCLUDING THOSE WITH ACUTE CORONARY SYNDROME (ACUTE MYOCARDIAL INFARCTION AND UNSTABLE ANGINA), DIABETES MELLITUS, RENAL FAILURE, OR WHO ARE AT HIGH RISK OF HEMORRAGIA._x000D_ IT IS ALSO INDICATED FOR USE IN THE FOLLOWING TIPOS_x000D_ CORONARY LESIONS:_x000D_ Or BIFURCACIÓN_x000D_ OR OSTIALES_x000D_ INJURIES O LEFT MAIN CORONARY ARTERY WITHOUT PROTECCIÓN_x000D_ OR TOTAL_x000D_ OCLUSION OR RESTENOSIS IN THE STENT_x000D_ OR SAFENA_x000D_ VIN GRAFT OR ILLNESS MULTIVASCULAR_x000D_ THE LENGTH OF THE TREATED LESION MUST BE LESS THAN LA_x000D_ NOMINAL STENT LENGTH (8 MM, 12 MM, 16 MM, 20 MM, 24 MM, _x000D_ 28 MM, 32 MM, 38 MM AND 48 MM*) WITH A VASCULAR DIAMETER DE_x000D_ REFERENCE FROM 2.25 MM TO 5.00 MM**._x000D_ THE 48 MM LONG STENT IS NOT AVAILABLE CON_x000D_ 2.25 MM._x000D_ DIAMETER LENGTHS OF 8 MM, 38 MM AND 48 MM ARE NOT DISPONIBLES_x000D_ IN DIAMETERS OF 4.50 MM AND 5.00 MM. _x000D_