Singapore HSA registration DE0509010
Medtronic Onyx Frontier™ Zotarolimus-Eluting Coronary Stent System
Singapore·CLASS COM·Medtronic, Inc·Registered March 01, 2024Device 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 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
Product Owner
- Name
- Medtronic, Inc
- 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)
- ONYXNG20008X ONYXNG20012X ONYXNG20015X ONYXNG20018X ONYXNG20022X ONYXNG20026X ONYXNG20030X ONYXNG22508X ONYXNG22512X ONYXNG22515X ONYXNG22518X ONYXNG22522X ONYXNG22526X ONYXNG22530X ONYXNG22534X ONYXNG22538X ONYXNG25008X ONYXNG25012X ONYXNG25015X ONYXNG25018X ONYXNG25022X ONYXNG25026X ONYXNG25030X ONYXNG25034X ONYXNG25038X ONYXNG27508X ONYXNG27512X ONYXNG27515X ONYXNG27518X ONYXNG27522X ONYXNG27526X ONYXNG27530X ONYXNG27534X ONYXNG27538X ONYXNG30008X ONYXNG30012X ONYXNG30015X ONYXNG30018X ONYXNG30022X ONYXNG30026X ONYXNG30030X ONYXNG30034X ONYXNG30038X ONYXNG35008X ONYXNG35012X ONYXNG35015X ONYXNG35018X ONYXNG35022X ONYXNG35026X ONYXNG35030X ONYXNG35034X ONYXNG35038X ONYXNG40008X ONYXNG40012X ONYXNG40015X ONYXNG40018X ONYXNG40022X ONYXNG40026X ONYXNG40030X ONYXNG40034X ONYXNG40038X ONYXNG45012X ONYXNG45015X ONYXNG45018X ONYXNG45022X ONYXNG45026X ONYXNG45030X ONYXNG50012X ONYXNG50015X ONYXNG50018X ONYXNG50022X ONYXNG50026X ONYXNG50030X
About this record
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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