Philippines FDA registration MDR-00943

DURATA™ ACTIVE-FIXATION TRUE DUAL-COIL STEROID-ELUTING ENDOCARDIAL DEFIBRILLATION LEAD

Philippines flagPhilippines·St. Jude Medical (Singapore) Pte. Ltd.·Singapore·Issued October 11, 2018 – November 20, 2023
Device information
Product Name
DURATA™ ACTIVE-FIXATION TRUE DUAL-COIL STEROID-ELUTING ENDOCARDIAL DEFIBRILLATION LEAD
Registration Number
MDR-00943
Manufacturer details
Country of Origin
Singapore
Importer & distribution
Importer/Distributor
Biodevices Inc.
Registration dates
Issuance Date
October 11, 2018
Expiry Date
November 20, 2023
About this record

Access comprehensive regulatory information for DURATA™ ACTIVE-FIXATION TRUE DUAL-COIL STEROID-ELUTING ENDOCARDIAL DEFIBRILLATION LEAD in the Philippines medical device market through Pure Global AI's free database. This device is registered under FDA registration number MDR-00943 and manufactured by St. Jude Medical (Singapore) Pte. Ltd. in Singapore. The device was registered on October 11, 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.

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