ISOFLEX™ OPTIM 1948 LEAD IMPLANTABLE CARDIOVERTER DEFIBRILLATOR - FDA Registration MDR-00800

Access comprehensive regulatory information for ISOFLEX™ OPTIM 1948 LEAD IMPLANTABLE CARDIOVERTER DEFIBRILLATOR in the Philippines medical device market through Pure Global AI's free database. This device is registered under FDA registration number MDR-00800 and manufactured by St. Jude Medical (Singapore) Pte. Ltd. in Singapore. The device was registered on August 31, 2018.

This page provides complete registration details including manufacturer information, importer/distributor details (Biodevices Inc.), and regulatory compliance data from the official Philippines FDA medical device database. Pure Global AI offers free access to Philippines' complete medical device registry, helping global MedTech companies navigate FDA regulations efficiently.