FDA.reportPublic FDA data

Evera™ XT DR

Primary DI
00763000059699
Brand
Evera™ XT DR
Company
MEDTRONIC, INC.
Model
DDBB1D4
Device description
ICD-DR DDBB1D4 EVERA XT US IS1/DF4
Published
2017-10-21
Public version status
Update
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)
NVZPulse generator, permanent, implantable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LWSImplantable Cardioverter Defibrillator (Non-Crt)Unknown3
NVZPulse Generator, Permanent, ImplantableUnknown3

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00763000059699PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00763000059699007630000596997630000596990763000059699

GMDN Terms#

Term, Definition table
TermDefinition
Dual-chamber implantable defibrillatorAn implantable pulse generator with a cardiac rhythm recognition system, to analyse an electrocardiogram (ECG), that delivers an electrical impulse(s) to defibrillate the heart (restore normal rhythm) or slow a rapid heart rate and to pace the heart in cases of bradycardia. It is implanted in a pouch beneath the skin of the patient's chest or abdomen and has connected leads that are positioned inside or on two same-side heart chambers (atrium and ventricle) to monitor the ECG and to automatically deliver the electrical impulse. The device has internal batteries that provide the energy to deliver the impulses; it is commonly known as an automatic implantable cardioverter-defibrillator (AICD).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Fahrenheit131 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
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00763000923594HeartWare™ Monitor1521MCS2026-09-25
00763000923709Power CordMCS1621PC2026-09-25
00763000923792Monitor Power CordMCS1622PC2026-09-25
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
00643169735668Serena™ Quad CRT-P MRI SureScan™W4TR022017-06-18
00643169735675Solara™ CRT-P MRI SureScan™W1TR032017-06-18
00643169891401Percepta™ CRT-P MRI SureScan™W1TR012017-10-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000368470Aurora EV-ICD™ MRI SureScan™MEDTRONIC, INC.LWS2023-11-02
04035479173937Solvia Rise SR-TBIOTRONIK SE & Co. KGNVZ2023-07-12
04035479173944Solvia Rise DR-TBIOTRONIK SE & Co. KGNVZ2023-07-12
04035479173982Amvia Edge SR-TBIOTRONIK SE & Co. KGNVZ2023-07-12
04035479173999Amvia Edge DR-TBIOTRONIK SE & Co. KGNVZ2023-07-12
04035479174019Amvia Sky SR-TBIOTRONIK SE & Co. KGNVZ2023-07-12
04035479174026Amvia Sky DR-TBIOTRONIK SE & Co. KGNVZ2023-07-12
00643169720589Evera MRI™ S VR SureScan®MEDTRONIC, INC.NVZ2020-11-13
04035479147686Evity 6 DR-TBIOTRONIK SE & Co. KGNVZ2020-09-15
00763000060015Evera MRI™ S DR SureScan™MEDTRONIC, INC.LWS2020-09-04
00763000060060Visia AF MRI™ S VR SureScan™MEDTRONIC, INC.NVZ2020-09-04
00763000060107Visia AF MRI™ S VR SureScan™MEDTRONIC, INC.LWS2020-09-04
00643169552272MyCareLink™MEDTRONIC, INC.NVZ2019-08-11
00763000059477NAMEDTRONIC, INC.NVZ2018-12-28
00763000001513Primo MRI™ DR SureScan™MEDTRONIC, INC.LWS2018-06-02
00763000001551Primo MRI™ VR SureScan™MEDTRONIC, INC.LWS2018-06-02
00643169634589Azure™ XT DR MRI SureScan™MEDTRONIC, INC.NVZ2017-12-02
00643169634602Azure™ S DR MRI SureScan™MEDTRONIC, INC.NVZ2017-12-02
00643169634640Azure™ S SR MRI SureScan™MEDTRONIC, INC.NVZ2017-12-02
00643169725379MyCareLink™MEDTRONIC, INC.NVZ2017-11-16
00643169871922Azure™ S DR MRI SureScan™MEDTRONIC, INC.NVZ2017-11-02
00643169871939Azure™ XT DR MRI SureScan™MEDTRONIC, INC.NVZ2017-11-02
00643169871977Azure™ S SR MRI SureScan™MEDTRONIC, INC.NVZ2017-11-02
00763000059569Evera™ XT DRMEDTRONIC, INC.LWS2017-10-21
00763000059705Evera MRI™ S DR SureScan®MEDTRONIC, INC.NVZ2017-10-21
00763000059705Evera MRI™ S DR SureScan®MEDTRONIC, INC.LWS2017-10-21
00763000059491Evera MRI™ XT DR SureScan®MEDTRONIC, INC.LWS2017-10-20
00763000059491Evera MRI™ XT DR SureScan®MEDTRONIC, INC.NVZ2017-10-20
00763000059507Visia AF MRI™ VR SureScan™MEDTRONIC, INC.LWS2017-10-20
00763000059521Evera MRI™ XT DR SureScan®MEDTRONIC, INC.NVZ2017-10-20