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Medtronic Onyx Frontier™ Zotarolimus-Eluting Coronary Stent System - HSA Registration DE0509010

Access comprehensive regulatory information for Medtronic Onyx Frontier™ Zotarolimus-Eluting Coronary Stent System in the Singapore medical device market through Pure Global AI's free database. This CLASS COM medical device is registered under HSA registration number DE0509010 and owned by Medtronic, Inc. The device was registered on March 01, 2024.

This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.

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CLASS COM
DE0509010
Medtronic Onyx Frontier™ Zotarolimus-Eluting Coronary Stent System
HSA Registration Number: DE0509010
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Product Description

The Onyx Frontier stent system is intended for use in patients eligible for percutaneous transluminal coronary angioplasty (PTCA) with a reference vessel diameter of 2.0 mm to 5.0 mm. The stent is indicated for the treatment of the following patient and lesion subsets: • Diabetes mellitus • Multivessel disease • Acute coronary syndrome (ACS) • Acute myocardial infarction (AMI) • Unstable angina (UA) • Bifurcation lesions • In-stent restenosis (ISR) • Chronic total occlusions (CTO) • Total occlusions (TO) • Left main (LM) • Small vessel (SV) • One month of dual anti-platelet therapy (DAPT) in high bleeding risk (HBR) patients, including patients unable to tolerate long term DAPT

Device Classification
Device Class
CLASS COM
Medical Speciality Area
Cardiovascular
Registration Information
Registration Number
DE0509010
Registration Date
March 01, 2024
Change Notification Approval Date
January 27, 2025
Retention Due Date
February 28, 2026
Product Owner
Short Name
Medtronic, Inc
Address
710 Medtronic Parkway, Minneapolis, MN 55432, UNITED STATES
Registrant
Address
50 PASIR PANJANG ROAD, MAPLETREE BUSINESS CITY, #04-51, SINGAPORE 117384
Importer
Address
50 PASIR PANJANG ROAD, MAPLETREE BUSINESS CITY, #04-51, SINGAPORE 117384 50 PASIR PANJANG ROAD, MAPLETREE BUSINESS CITY, #04-51, SINGAPORE 117384
Model Information
Model Name(s)
Onyx Frontier™ Zotarolimus-Eluting Coronary Stent System Onyx Frontier™ Zotarolimus-Eluting Coronary Stent System Onyx Frontier™ Zotarolimus-Eluting Coronary Stent System Onyx Frontier™ Zotarolimus-Eluting Coronary Stent System Onyx Frontier™ Zotarolimus-Eluting Coronary Stent System Onyx Frontier™ Zotarolimus-Eluting Coronary Stent System Onyx Frontier™ Zotarolimus-Eluting Coronary Stent System Onyx Frontier™ Zotarolimus-Eluting Coronary Stent System Onyx Frontier™ Zotarolimus-Eluting Coronary Stent System Onyx Frontier™ Zotarolimus-Eluting Coronary Stent System Onyx Frontier™ Zotarolimus-Eluting Coronary Stent System Onyx Frontier™ Zotarolimus-Eluting Coronary Stent System Onyx Frontier™ Zotarolimus-Eluting Coronary Stent System Onyx Frontier™ Zotarolimus-Eluting Coronary Stent System Onyx Frontier™ Zotarolimus-Eluting Coronary Stent System Onyx Frontier™ Zotarolimus-Eluting Coronary Stent System Onyx Frontier™ Zotarolimus-Eluting Coronary Stent System Onyx Frontier™ Zotarolimus-Eluting Coronary Stent System Onyx Frontier™ Zotarolimus-Eluting Coronary Stent System Onyx Frontier™ Zotarolimus-Eluting Coronary Stent System Onyx Frontier™ Zotarolimus-Eluting Coronary Stent System Onyx Frontier™ Zotarolimus-Eluting Coronary Stent System Onyx Frontier™ Zotarolimus-Eluting Coronary Stent System Onyx Frontier™ Zotarolimus-Eluting Coronary Stent System Onyx Frontier™ Zotarolimus-Eluting Coronary Stent System Onyx Frontier™ Zotarolimus-Eluting Coronary Stent System Onyx Frontier™ Zotarolimus-Eluting Coronary Stent System Onyx Frontier™ Zotarolimus-Eluting Coronary Stent System Onyx Frontier™ Zotarolimus-Eluting Coronary Stent System Onyx Frontier™ Zotarolimus-Eluting Coronary Stent System Onyx Frontier™ Zotarolimus-Eluting Coronary Stent System Onyx Frontier™ Zotarolimus-Eluting Coronary Stent System Onyx Frontier™ Zotarolimus-Eluting Coronary Stent System Onyx Frontier™ Zotarolimus-Eluting Coronary Stent System Onyx Frontier™ Zotarolimus-Eluting Coronary Stent System Onyx Frontier™ Zotarolimus-Eluting Coronary Stent System Onyx Frontier™ Zotarolimus-Eluting Coronary Stent System Onyx Frontier™ Zotarolimus-Eluting Coronary Stent System Onyx Frontier™ Zotarolimus-Eluting Coronary Stent System Onyx Frontier™ Zotarolimus-Eluting Coronary Stent System Onyx Frontier™ Zotarolimus-Eluting Coronary Stent System Onyx Frontier™ Zotarolimus-Eluting Coronary Stent System Onyx Frontier™ Zotarolimus-Eluting Coronary Stent System Onyx Frontier™ Zotarolimus-Eluting Coronary Stent System Onyx Frontier™ Zotarolimus-Eluting Coronary Stent System Onyx Frontier™ Zotarolimus-Eluting Coronary Stent System Onyx Frontier™ Zotarolimus-Eluting Coronary Stent System Onyx Frontier™ Zotarolimus-Eluting Coronary Stent System Onyx Frontier™ Zotarolimus-Eluting Coronary Stent System Onyx Frontier™ Zotarolimus-Eluting Coronary Stent System Onyx Frontier™ Zotarolimus-Eluting Coronary Stent System Onyx Frontier™ Zotarolimus-Eluting Coronary Stent System Onyx Frontier™ Zotarolimus-Eluting Coronary Stent System Onyx Frontier™ Zotarolimus-Eluting Coronary Stent System Onyx Frontier™ Zotarolimus-Eluting Coronary Stent System Onyx Frontier™ Zotarolimus-Eluting Coronary Stent System Onyx Frontier™ Zotarolimus-Eluting Coronary Stent System Onyx Frontier™ Zotarolimus-Eluting Coronary Stent System Onyx Frontier™ Zotarolimus-Eluting Coronary Stent System Onyx Frontier™ Zotarolimus-Eluting Coronary Stent System Onyx Frontier™ Zotarolimus-Eluting Coronary Stent System Onyx Frontier™ Zotarolimus-Eluting Coronary Stent System Onyx Frontier™ Zotarolimus-Eluting Coronary Stent System Onyx Frontier™ Zotarolimus-Eluting Coronary Stent System Onyx Frontier™ Zotarolimus-Eluting Coronary Stent System Onyx Frontier™ Zotarolimus-Eluting Coronary Stent System Onyx Frontier™ Zotarolimus-Eluting Coronary Stent System Onyx Frontier™ Zotarolimus-Eluting Coronary Stent System Onyx Frontier™ Zotarolimus-Eluting Coronary Stent System Onyx Frontier™ Zotarolimus-Eluting Coronary Stent System Onyx Frontier™ Zotarolimus-Eluting Coronary Stent System Onyx Frontier™ Zotarolimus-Eluting Coronary Stent System Onyx Frontier™ Zotarolimus-Eluting Coronary Stent System
Model Identifier(s)
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