HSA · registration DE0509010Medtronic Onyx Frontier™ Zotarolimus-Eluting Coronary Stent System
SingaporeCardiovascularClass DMedtronic, Inc
Official record identity
- Registration number
- DE0509010
- Model name
- 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
- 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
- Registration date
- March 01, 2024
- Source update date
- January 27, 2025
Classification
- Risk class
- Class D
Official value: D WITH MEDICINAL PRODUCT
Published parties
- Product owner
- Medtronic, Inc
- Registrant / registration holder
- MEDTRONIC INTERNATIONAL, LTD. (Singapore Branch)
Official 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
Additional source fields
- Product owner address
- 710 Medtronic Parkway, Minneapolis, MN 55432, United States
- Registrant address
- 50 PASIR PANJANG ROAD, #04-51, MAPLETREE BUSINESS CITY, Singapore 117384
About this record
This page mirrors one row from HSA’s official registered-medical-device workbook. Product owner and registrant are separate published roles; neither is relabeled as the manufacturer. The official NOT_GENERATED value is retained when HSA does not publish a registration number, and the device name remains part of the stable record identity.