Identity
- Trade Name
- ELUVIA™ FDA UDI
- Generic Name
- Drug-eluting peripheral artery stent, bare-metal FDA UDI
- Device Name
- Drug-Eluting Vascular Stent System FDA UDI
- Model / Reference
- H74939294601270 FDA UDI
- Description
- Drug-Eluting Vascular Stent System FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08714729876557 FDA UDI
- PMA Number
- P180011 FDA UDI
- FDA Product Code
- NIU FDA UDI
- GMDN Term
- Drug-eluting peripheral artery stent, bare-metal FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
Yes
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Conditional FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 6 Millimeter FDA UDILength — 120 Millimeter FDA UDILength — 75 Centimeter FDA UDI
Category: Drug-eluting peripheral artery stent, bare-metal
Eluvia™ by Boston Scientific — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
P180011 also covers:
- ELUVIA™ — Boston Scientific
- ELUVIA™ — Boston Scientific
- ELUVIA™ — Boston Scientific
- ELUVIA™ — Boston Scientific
- ELUVIA™ — Boston Scientific
- ELUVIA™ — Boston Scientific
- ELUVIA™ — Boston Scientific
- ELUVIA™ — Boston Scientific
- ELUVIA™ — Boston Scientific
- ELUVIA™ — Boston Scientific
- ELUVIA™ — Boston Scientific
- ELUVIA™ — Boston Scientific
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
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
- Boston Scientific
Sources (1)
- FDA UDI ce535907-4dad-413a-8089-e66cc3d5c3cd 35 fields · synced May 30, 2026