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IHTDESTINY® SISTEMA DE STENTCORONARIO CON ELUCIÓN DESIROLIMUS - COFEPRIS Registration 1349C2021 SSA

Access comprehensive regulatory information for IHTDESTINY® SISTEMA DE STENTCORONARIO CON ELUCIÓN DESIROLIMUS (IHTDESTINY® CORONARY STENT SYSTEM WITH ELUTION DESIROLIMUS) in the Mexico medical device market through Pure Global AI's free database. This Clase III medical device is registered under COFEPRIS analysis ID 1349C2021 SSA and manufactured by MEDSTENT, S.A. DE C.V.. The device was registered on June 09, 2021.

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.

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COFEPRIS Official Data
Clase III
1349C2021 SSA
IHTDESTINY® SISTEMA DE STENTCORONARIO CON ELUCIÓN DESIROLIMUS
COFEPRIS Analysis ID: 1349C2021 SSA
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Product Use / Uso del Producto
Spanish

EL SISTEMA DE STENT CORONARIO CONELUCIÓN DE SIROLIMUS IHTDESTINY® ESTÁINDICADO PARA SU UTILIZACIÓN EN LAANGIOPLASTIA CORONARIA TRANSLUMINALPERCUTÁNEA (ACTP) PARA LA DILATACIÓNPERMANENTEDELAPARTEESTENÓTICADEUNAARTERIACORONARIANATIVA,MEDIANTELACOLOCACIÓN DEUN STENT CORONARIOCON EL FIN DE MEJORAR LA PERFUSIÓNMIOCÁRDICA.

English

THE SIROLIMUS IHTDESTINY® CORONARY STENT SYSTEM IS INDICATED FOR USE IN TRANSLUMINALPERCUTANEOUS CORONARY ANGIOPLASTY (PTCA) FOR PERMANENT DILATION OF THE STENOTIC PART OF A CORONARY ARTERY BY CORONARY STENTING TO IMPROVE MYOCARDIAL PERFUSION.

Device Classification
Risk Class / Clase de Riesgo
Clase III
Product Type (Spanish)
II. PROTESIS, ÓRTESIS Y AYUDAS FUNCIONALES
Product Type (English)
II. PROSTHETICS, ORTHOSES AND FUNCTIONAL AIDS
Trade Name (Spanish)
SISTEMA DE STENT CORONARIO CONELUCIÓN DE SIROLIMUS
Trade Name (English)
CORONARY STENT SYSTEM CONELUTION OF SIROLIMUS
Registration Information
Analysis ID
1349C2021 SSA
Registration Date
June 09, 2021
Manufacturer / Fabricante
Name (English)
MEDSTENT, S.A. DE C.V.