Medical Device Division · registration 240352ActiveMedtronic, Inc.
Hong KongStents, Vascular, Coronary, Balloon-Expandable, Drug-ElutingClass IVMedtronic, Inc.
Official record identity
- MDACS listing number
- 240352
- Model name
- Onyx Frontier Zotarolimus-Eluting Coronary Stent System (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
- August 29, 2024
- Expiry date
- August 28, 2029
- Source update date
- November 05, 2024
- Status
- Active
Official value: Valid
Classification
- Risk class
- Class IV
- Published category
- Stents, Vascular, Coronary, Balloon-Expandable, Drug-Eluting
Official value: IV
Published parties
- Registrant / registration holder
- Medtronic Hong Kong Medical Limited
- Manufacturer
- Medtronic, Inc.
Official description
Stents, Vascular, Coronary, Balloon-Expandable, Drug-Eluting
Additional source fields
- AMD nomenclature code
- 20383
- Traditional Chinese local responsible person
- 美敦力香港醫療有限公司
- Local responsible person phone
- 29191300
- Published manufacturer address
- 710 Medtronic Parkway, Minneapolis, Minnesota, 55432, USA
About this record
This page mirrors one official MDACS listing. Roman-numeral classes use Hong Kong’s general medical-device scheme, while letter classes use the IVD scheme. Valid, expired, and delisted records remain distinguishable; no mixed classification scale is fabricated.