Identity
- Trade Name
- Resolute Onyx™ FDA UDI
- Generic Name
- Drug-eluting coronary artery stent, non-bioabsorbable-polymer-coated FDA UDI
- Device Name
- STENT RONYX50026UX RESOLUTE ONYX 5.00X26 FDA UDI
- Model / Reference
- RONYX50026UX FDA UDI
- Description
- STENT RONYX50026UX RESOLUTE ONYX 5.00X26 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00643169557338 FDA UDI
- PMA Number
- P160043 FDA UDI
- FDA Product Code
- NIQ FDA UDI
- GMDN Term
- Drug-eluting coronary artery stent, non-bioabsorbable-polymer-coated FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
Yes
Contains Latex
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
Yes
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Dimensions & Sizes
- Size
- Length — 26.0 Millimeter FDA UDI
Category: Drug-eluting coronary artery stent, non-bioabsorbable-polymer-coated
Resolute Onyx is a non-bioabsorbable metal tubular mesh structure designed to be implanted into a coronary artery (or saphenous vein graft) in patients with symptomatic atherosclerotic heart disease. It features a drug coating that slowly releases and inhibits restenosis by reducing vessel smooth muscle cell proliferation.
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Also classified as Drug-eluting coronary artery stent, non-bioabsorbable-polymer-coated.
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Cleared under the same submission
P160043 also covers:
- Onyx Frontier™ — MEDTRONIC, INC.
- Onyx Frontier™ — MEDTRONIC, INC.
- Onyx Frontier™ — MEDTRONIC, INC.
- Onyx Frontier™ — MEDTRONIC, INC.
- Onyx Frontier™ — MEDTRONIC, INC.
- Onyx Frontier™ — MEDTRONIC, INC.
- Onyx Frontier™ — MEDTRONIC, INC.
- Onyx Frontier™ — MEDTRONIC, INC.
- Onyx Frontier™ — MEDTRONIC, INC.
- Onyx Frontier™ — MEDTRONIC, INC.
- Onyx Frontier™ — MEDTRONIC, INC.
- Onyx Frontier™ — MEDTRONIC, INC.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | Pending data |
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Manufacturer
- Manufacturer
- Medtronic, Inc.
Sources (1)
- FDA UDI 501dfbd1-82cf-4fea-81d7-4b0b87395c72 37 fields · synced Oct 7, 2026