Aurora EV-ICD™ MRI SureScan™

FDA UDI

Class III (US FDA UDI)

by Medtronic, Inc.

Identity

Trade Name: Aurora EV-ICD™ MRI SureScan™ FDA UDI
Generic Name: Single-chamber implantable defibrillator FDA UDI
Device Name: ICD-VR DVEA3E4 EV-ICD EV4 US RW UPDATE FDA UDI
Model / Reference: DVEA3E4 FDA UDI
Description: ICD-VR DVEA3E4 EV-ICD EV4 US RW UPDATE FDA UDI

Identifiers

Primary DI / UDI-DI: 00763000368470 FDA UDI
PMA Number: P220012 FDA UDI
FDA Product Code: LWS FDA UDI
NVY FDA UDI
GMDN Term: Single-chamber implantable defibrillator 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

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Conditional FDA UDI

Category: Single-chamber implantable defibrillator

Aurora EV-ICD™ MRI SureScan™ by Medtronic, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Single-chamber implantable defibrillator.

Fortify Assura™ — ST. JUDE MEDICAL, INC. · Class III
Ellipse™ — ST. JUDE MEDICAL, INC. · Class III
Rivacor 5 VR-T DF4 ProMRI — BIOTRONIK SE & Co. KG · Class III
DYNAGEN™ EL ICD VR — Boston Scientific · Class III
Gallant™ — ST. JUDE MEDICAL, INC. · Class III
Paradym RF — MICROPORT CRM SRL · Class III
FORTIFY™ — ST. JUDE MEDICAL, INC. · Class III
Intica 7 VR-T DX DF-1 ProMRI — BIOTRONIK SE & Co. KG · Class III

Cleared under the same submission

P220012 also covers:

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: Medtronic, Inc.

Sources (1)

FDA UDI dd3893ab-34ff-48b3-9f02-19eb0c2870fa 36 fields · synced May 30, 2026