Epsila EV™ MRI SureScan™

FDA UDI

Class III (US FDA UDI)

by Medtronic, Inc.

Identity

Trade Name: Epsila EV™ MRI SureScan™ FDA UDI
Generic Name: Endocardial defibrillation lead FDA UDI
Device Name: LEAD EV240152 SUBSTERNAL LEAD 52CM FDA UDI
Model / Reference: EV240152 FDA UDI
Description: LEAD EV240152 SUBSTERNAL LEAD 52CM FDA UDI

Identifiers

Primary DI / UDI-DI: 00763000369767 FDA UDI
PMA Number: P220012 FDA UDI
FDA Product Code: LWS FDA UDI
NVY FDA UDI
GMDN Term: Endocardial defibrillation lead 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

Dimensions & Sizes

Size: Length — 52.0 Centimeter FDA UDI

Category: Endocardial defibrillation lead

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

Similar devices

Also classified as Endocardial defibrillation lead.

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ENDOTAK RELIANCE® G — Boston Scientific · Class III
Pamira SD 65/18 — BIOTRONIK SE & Co. KG · Class III
Durata™ — ST. JUDE MEDICAL, INC. · Class III
Plexa ProMRI SD 60/16 — BIOTRONIK SE & Co. KG · Class III
D2-Kit — 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 0ccf001c-5f8c-4106-b7d7-de5daad10d21 37 fields · synced May 30, 2026