FDA.reportPublic FDA data

Epsila EV™

Primary DI
00763000369736
Brand
Epsila EV™
Company
MEDTRONIC, INC.
Model
EAZ101
Device description
TOOL EAZ101 TUNNELING ZONE 1
Published
2023-11-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LWSImplantable cardioverter defibrillator (non-CRT)
NVYPermanent defibrillator electrodes

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LWSImplantable Cardioverter Defibrillator (Non-Crt)Unknown3
NVYPermanent Defibrillator ElectrodesUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P220012000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P220012000Aurora EV-ICD SystemMedtronic, Inc.2023-10-20LWS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00763000369736PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00763000369736007630003697367630003697360763000369736

GMDN Terms#

Term, Definition table
TermDefinition
Pacing/defibrillation lead tunnellerA sterile hand-held manual surgical instrument designed to create a tunnel (an artificial passageway) through subcutaneous tissue for the placement of an implantable extracardiac lead/electrode. It is a long, thin, semi-flexible rod with a rounded distal tip and a handle at the proximal end to allow the surgeon to push through body tissues; it may include an integrated sheath (e.g., split sheath) intended to assist lead placement. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature-31 Degrees Fahrenheit136 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-8766Corporate.UDI@medtronic.com

Regulatory Flags#

DUNS number
006261481
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00763000387020Symplicity G3™RDNG3A2023-11-30
00824846020073NABB10E56R162026-10-01
00643169845893Reveal LINQ™LNQ112020-01-19
00199150032402SenSight™B31030-S2026-09-28
00199150032426SenSight™B31030-D2026-09-28
00763000923709Power CordMCS1621PC2026-09-25
00763000443214NA2ACHC2024-05-18
00763000368470Aurora EV-ICD™ MRI SureScan™DVEA3E42023-11-02
00763000001513Primo MRI™ DR SureScan™DDMD3D42018-06-02
00763000001551Primo MRI™ VR SureScan™DVMD3D42018-06-02
00763000059491Evera MRI™ XT DR SureScan®DDMB1D42017-10-20
00763000059651Viva™ Quad XT CRT-DDTBA1QQ2017-10-21
00763000059668Viva™ XT CRT-DDTBA1D42017-10-21
00763000059705Evera MRI™ S DR SureScan®DDMC3D42017-10-21
00643169314092Evera MRI™ XT DR SureScan®DDMB1D42015-09-21
00643169314153Evera MRI™ XT VR SureScan®DVMB1D42015-09-21
00643169720497Evera MRI™ XT DR SureScan®DDMB1D42017-09-15
00643169735637Percepta™ CRT-P MRI SureScan™W1TR012017-06-18
00643169735644Percepta™ Quad CRT-P MRI SureScan™W4TR012017-06-18
00643169735651Serena™ CRT-P MRI SureScan™W1TR022017-06-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00802526623400NABOSTON SCIENTIFIC CORPORATIONLWS2024-08-29
00763000368470Aurora EV-ICD™ MRI SureScan™MEDTRONIC, INC.LWS2023-11-02
00763000368470Aurora EV-ICD™ MRI SureScan™MEDTRONIC, INC.NVY2023-11-02
00802526496868RELIANCE 4-FRONT™BOSTON SCIENTIFIC CORPORATIONNVY2018-08-25
00802526496967RELIANCE 4-FRONT™BOSTON SCIENTIFIC CORPORATIONNVY2018-08-25
00802526496981RELIANCE 4-FRONT™BOSTON SCIENTIFIC CORPORATIONNVY2018-08-25
00802526497001RELIANCE 4-FRONT™BOSTON SCIENTIFIC CORPORATIONNVY2018-08-25
00802526592805RELIANCE 4-FRONT™BOSTON SCIENTIFIC CORPORATIONNVY2018-08-25
00802526592829RELIANCE 4-FRONT™BOSTON SCIENTIFIC CORPORATIONNVY2018-08-25
00802526592850RELIANCE 4-FRONT™BOSTON SCIENTIFIC CORPORATIONNVY2018-08-25
00802526592867RELIANCE 4-FRONT™BOSTON SCIENTIFIC CORPORATIONNVY2018-08-25
00763000001513Primo MRI™ DR SureScan™MEDTRONIC, INC.LWS2018-06-02
00763000001551Primo MRI™ VR SureScan™MEDTRONIC, INC.LWS2018-06-02
00643169410954CapSure Sense MRI™ SureScan™MEDTRONIC, INC.NVY2017-10-26
00643169448957CapSure Sense MRI™ SureScan™MEDTRONIC, INC.NVY2017-10-26
00763000059705Evera MRI™ S DR SureScan®MEDTRONIC, INC.LWS2017-10-21
00763000059491Evera MRI™ XT DR SureScan®MEDTRONIC, INC.LWS2017-10-20
00802526599200EMBLEM™ S-ICDBOSTON SCIENTIFIC CORPORATIONLWS2017-10-12
00643169720497Evera MRI™ XT DR SureScan®MEDTRONIC, INC.LWS2017-09-15
00643169453180CapSureFix™ NovusMEDTRONIC, INC.NVY2017-06-02
00643169633735CapSureFix Novus MRI™ SureScan®MEDTRONIC, INC.NVY2017-06-02
00643169633742CapSureFix Novus MRI™ SureScan®MEDTRONIC, INC.NVY2017-06-02
00643169633766CapSureFix Novus MRI™ SureScan®MEDTRONIC, INC.NVY2017-06-02
00643169633773CapSureFix Novus MRI™ SureScan®MEDTRONIC, INC.NVY2017-06-02
00643169633780CapSureFix Novus MRI™ SureScan®MEDTRONIC, INC.NVY2017-06-02
00643169929876Evera™ S VRMEDTRONIC, INC.LWS2017-05-22
00643169410916CapSure Sense MRI™ SureScan™MEDTRONIC, INC.NVY2017-02-05
00643169448858CapSure Sense MRI™ SureScan™MEDTRONIC, INC.NVY2017-02-05
00643169448865CapSure Sense MRI™ SureScan™MEDTRONIC, INC.NVY2017-02-05
00643169708174CapSureFix Novus MRI™ SureScan™MEDTRONIC, INC.NVY2016-12-26