ROTAPRO - COFEPRIS Registration 158E2021 SSA
Access comprehensive regulatory information for ROTAPRO (ROTAPRO) in the Mexico medical device market through Pure Global AI's free database. This Clase III medical device is registered under COFEPRIS analysis ID 158E2021 SSA and manufactured by BOSTONSCIENTIFICDEMÉXICO, S.A. DE C.V.. The device was registered on February 08, 2021.
This page provides complete registration details including product type (I. MEDICAL EQUIPMENT), 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 ATERECTOMÍA CORONARIA ROTATIVAPERCUTÁNEA CON EL SISTEMA DEATERECTOMÍA ROTATIVA ROTAPRO, COMOTRATAMIENTO ÚNICO O COMBINADO CONUNA INTERVENCIÓN CORONARIAPERCUTÁNEA (ICP), ESTÁ INDICADA PARAPACIENTES CON ENFERMEDAD DE LAARTERIACORONARIACÁLCICAQUECUMPLENUNO DE LOS SIGUIENTES CRITERIOS DESELECCIÓN: • ATEROSCLEROSISCORONARIADEUNSOLOVASOCONUNAESTENOSISQUEPERMITA INTRODUCIR UNA GUÍA. •ENFERMEDADDELAARTERIACORONARIADEVARIOS VASOS QUE, AJUICIO DEL MÉDICO,
PERCUTANEOUS ROTATIVE CORONARY ATHERECTOMY WITH THE ROTAPRO ROTARY ATHERECTOMY SYSTEM, AS A SINGLE OR COMBINED TREATMENT WITH PERCUTANEOUS CORONARY INTERVENTION (PCI), IS INDICATED FOR PATIENTS WITH CORONARY ARTERY DISEASE WHO MEET ONE OF THE FOLLOWING SELECTION CRITERIA: • CORONARY ATHEROSCLEROSIS OF A SINGLE VASOCONA STENOSIS, ALLOWING A GUIDE TO BE INTRODUCED. •CORONARY ARTERY DISEASE OF SEVERAL VESSELS WHICH, IN THE OPINION OF THE DOCTOR,