FDA.reportPublic FDA data

Edora 8 HF-T

Primary DI
04035479147570
Brand
Edora 8 HF-T
Company
BIOTRONIK SE & Co. KG
Model
407138
Catalog number
407138
Published
2017-04-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NKEPulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NKEPulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)Unknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P070008076

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P070008076STRATOS LV CRT-P AND STRATOS LV-T CRT-P, COROX OTW BP LEAD AND COROX OTW-S BP LEADBiotronik, Inc.2008-05-12NKE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04035479147570PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04035479147570040354791475704035479147570

GMDN Terms#

Term, Definition table
TermDefinition
Cardiac resynchronization therapy implantable pacemakerA battery-powered, hermetically-sealed pulse generator, intended to be implanted beneath the skin of the chest in a surgically-created pocket, and used with pacing leads placed in the right ventricle, in a coronary vein over the left ventricle, and often in the right atrium (triple chamber) to stimulate the heart to beat at a faster rate when it senses bradycardia and provides cardiac resynchronization therapy (CRT) through biventricular electrical stimulation to synchronize right and left ventricular contractions to treat symptoms of heart failure (e.g., easy fatigue) and serious heart-rhythm problems [CRT pacemaker (CRT-P)]; it is not intended for defibrillation therapy.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(888)345-0374jon.brumbaugh@biotronik.com

Regulatory Flags#

DUNS number
315620229
Device count
1
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04035479110048Reocor S3655283655282014-08-13
04035479110055Reocor D3655293655292014-08-13
04035479114336Reocor D Redeladapter3712623712622014-08-21
04035479114343Reocor S Redeladapter3712633712632014-08-21
04035479114510Renamic PGH3715883715882014-08-21
04035479114527Renamic PGH ICD3715893715892014-08-21
04035479115142Renamic3719603719602014-08-12
04035479126391Renamic PSA Module3866103866102014-08-15
04035479143848Home Monitoring Service Center3.274053312014-08-21
04035479144241Home Monitoring Service Center3.284055522014-09-19
04035479144791BS IS-13308343308342014-08-04
04035479144807DH3316683316682014-08-14
04035479144968S 45-K1135881135882014-08-14
04035479144975S 45-S1300111300112014-08-14
04035479145019S 53-K1072351072352014-08-14
04035479145026S 53-S1300131300132014-08-14
04035479145033S 58-K1188771188772014-08-21
04035479148836Home Monitoring Service Center3.304084082015-04-22
04035479148850Home Monitoring Service Center3.324084102015-10-20
04035479152406Home Monitoring Service Center3.344193212016-04-18

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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05415067050045Neutrino™ST. JUDE MEDICAL, INC.NKE2025-02-11
05415067050052Gallant™ST. JUDE MEDICAL, INC.NKE2025-02-11
05415067050076Neutrino™ST. JUDE MEDICAL, INC.NKE2025-02-11
05415067050090Gallant™ST. JUDE MEDICAL, INC.NKE2025-02-11
05415067050106Entrant™ST. JUDE MEDICAL, INC.NKE2025-02-11
05415067050120Entrant™ST. JUDE MEDICAL, INC.NKE2025-02-11
05415067034809Merlin@home™ST. JUDE MEDICAL, INC.NKE2024-11-13
04035479174002Amvia Edge HF-T QPBIOTRONIK SE & Co. KGNKE2023-07-12
04035479174033Amvia Sky HF-TBIOTRONIK SE & Co. KGNKE2023-07-12
04035479174040Amvia Sky HF-T QPBIOTRONIK SE & Co. KGNKE2023-07-12
05415067040404NAST. JUDE MEDICAL, INC.NKE2023-01-09
00763000688479NAMEDTRONIC, INC.NKE2022-10-28
05415067031174Merlin™ST. JUDE MEDICAL, INC.NKE2022-08-29
05415067037121Merlin™ST. JUDE MEDICAL, INC.NKE2022-08-29
05414734510080Quadra Allure™ST. JUDE MEDICAL, INC.NKE2019-01-15
05414734510097Quadra Allure MP™ST. JUDE MEDICAL, INC.NKE2019-01-15
00763000060428NAMEDTRONIC, INC.NKE2018-12-16
00643169891401Percepta™ CRT-P MRI SureScan™MEDTRONIC, INC.NKE2017-10-20
00643169891418Percepta™ Quad CRT-P MRI SureScan™MEDTRONIC, INC.NKE2017-10-20
00643169891425Serena™ CRT-P MRI SureScan™MEDTRONIC, INC.NKE2017-10-20
00643169891432Serena™ Quad CRT-P MRI SureScan™MEDTRONIC, INC.NKE2017-10-20
00643169891449Solara™ CRT-P MRI SureScan™MEDTRONIC, INC.NKE2017-10-20
00643169891456Solara™ Quad CRT-P MRI SureScan™MEDTRONIC, INC.NKE2017-10-20
00643169735637Percepta™ CRT-P MRI SureScan™MEDTRONIC, INC.NKE2017-06-18
00643169735644Percepta™ Quad CRT-P MRI SureScan™MEDTRONIC, INC.NKE2017-06-18
00643169735651Serena™ CRT-P MRI SureScan™MEDTRONIC, INC.NKE2017-06-18
00643169735668Serena™ Quad CRT-P MRI SureScan™MEDTRONIC, INC.NKE2017-06-18
00643169735675Solara™ CRT-P MRI SureScan™MEDTRONIC, INC.NKE2017-06-18
00643169735682Solara™ Quad CRT-P MRI SureScan™MEDTRONIC, INC.NKE2017-06-18