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
00763000862336MyCareLink™249552026-07-26
00763000060374LINQ II™LNQ222020-07-18
00763000422615SYNCHROMED®II8637-402021-04-11
00763000634094SYNCHROMED® II8637-202022-08-11
00763000634100SYNCHROMED® II8637-402022-08-11
00643169508149SYNCHROMED® II8637-202016-04-27
00643169508156SYNCHROMED® II8637-402016-04-27
00643169630505SYNCHROMED® II8637-202018-08-17
00643169630512SYNCHROMED® II8637-402018-08-17
00643169100824SYNCHROMED ® II8637-402016-04-27
00643169100831SYNCHROMED ® II8637-202016-04-27
00199150084036MiniMed Flex Starter KitMMT-8076B2026-07-19
00199150084043MiniMed Flex Starter KitMMT-8076C2026-07-19
00199150084050MiniMed Extended Supply KitMMT-445B2026-07-19
00199150084067MiniMed Extended Supply KitMMT-445C2026-07-19
00824846004721NABB12S95R52026-07-19
00824846004738NABB12S26R2026-07-19
00824846004028NABB5722R492026-07-16
00824846003151NABB9F19R82026-07-09
00763000520083N/AA712002021-07-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00643169410954CapSure Sense MRI™ SureScan™MEDTRONIC, INC.NVY2017-10-26
00643169448957CapSure Sense MRI™ SureScan™MEDTRONIC, INC.NVY2017-10-26
00643169988651Visia AF MRI™ S VR SureScan™MEDTRONIC, INC.LWS2017-09-25
00643169720374Evera™ XT DRMEDTRONIC, INC.LWS2017-09-15
00643169720527Evera MRI™ S DR SureScan®MEDTRONIC, INC.LWS2017-09-15
00643169720558Evera MRI™ XT VR SureScan®MEDTRONIC, INC.LWS2017-09-15
00643169720626Visia AF™ VRMEDTRONIC, INC.LWS2017-09-15
00643169720794Visia AF MRI™ VR SureScan™MEDTRONIC, INC.LWS2017-09-15
00643169837829Visa AF MRI™ S VR SureScan™MEDTRONIC, INC.LWS2017-09-15
00643169858305Sprint Quattro™ MRI SureScan™MEDTRONIC, INC.LWS2017-06-11
00643169858329Sprint Quattro™ MRI SureScan™MEDTRONIC, INC.NVY2017-06-11
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
00643169929258Evera MRI™ S DR SureScan™MEDTRONIC, INC.LWS2017-05-22
00643169929265Evera MRI™ S DR SureScan®MEDTRONIC, INC.LWS2017-05-22
00643169929944Visia AF MRI™ S VR SureScan™MEDTRONIC, INC.LWS2017-05-22
00643169857674SelectSecure™ MRI SureScan™MEDTRONIC, INC.NVY2017-05-21
00643169857681SelectSecure™ MRI SureScan™MEDTRONIC, INC.NVY2017-05-21
00643169857698SelectSecure™ MRI SureScan™MEDTRONIC, INC.NVY2017-05-21
00643169929197Evera MRI™ XT DR SureScan™MEDTRONIC, INC.LWS2017-05-14
00643169929760Visia AF™ VRMEDTRONIC, INC.LWS2017-05-14
00643169929913Visia AF MRI™ VR SureScan™MEDTRONIC, INC.LWS2017-05-12
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