FDA.reportPublic FDA data

VALITUDE™ X4 CRT-P

Primary DI
00802526559402
Brand
VALITUDE™ X4 CRT-P
Company
BOSTON SCIENTIFIC CORPORATION
Model
U128
Catalog number
U128
Device description
Cardiac Resynchronization Therapy Pacemaker
Published
2014-11-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

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
P030005113
P030005116
P030005119
P030005129
P030005133
P030005138
P030005156
P030005157
P030005164
P030005176
P030005180
P030005186
P030005201
P030005210
P030005220
P030005223
P030005225
P030005237
P030005240
P030005246
P030005250

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P030005113CONTAK RENEWAL MODELS H125 AND H120 WITH THE MODEL 2865 VERSION 1.8 APPLICATION SOFTWAREGuidant Corp.2004-01-26NKE
P030005116CONTAK RENEWAL MODELS H125 AND H120 WITH THE MODEL 2865 VERSION 1.8 APPLICATION SOFTWAREGuidant Corp.2004-01-26NKE
P030005119CONTAK RENEWAL MODELS H125 AND H120 WITH THE MODEL 2865 VERSION 1.8 APPLICATION SOFTWAREGuidant Corp.2004-01-26NKE
P030005129CONTAK RENEWAL MODELS H125 AND H120 WITH THE MODEL 2865 VERSION 1.8 APPLICATION SOFTWAREGuidant Corp.2004-01-26NKE
P030005133CONTAK RENEWAL MODELS H125 AND H120 WITH THE MODEL 2865 VERSION 1.8 APPLICATION SOFTWAREGuidant Corp.2004-01-26NKE
P030005138CONTAK RENEWAL MODELS H125 AND H120 WITH THE MODEL 2865 VERSION 1.8 APPLICATION SOFTWAREGuidant Corp.2004-01-26NKE
P030005156CONTAK RENEWAL MODELS H125 AND H120 WITH THE MODEL 2865 VERSION 1.8 APPLICATION SOFTWAREGuidant Corp.2004-01-26NKE
P030005157CONTAK RENEWAL MODELS H125 AND H120 WITH THE MODEL 2865 VERSION 1.8 APPLICATION SOFTWAREGuidant Corp.2004-01-26NKE
P030005164CONTAK RENEWAL MODELS H125 AND H120 WITH THE MODEL 2865 VERSION 1.8 APPLICATION SOFTWAREGuidant Corp.2004-01-26NKE
P030005176CONTAK RENEWAL MODELS H125 AND H120 WITH THE MODEL 2865 VERSION 1.8 APPLICATION SOFTWAREGuidant Corp.2004-01-26NKE
P030005180CONTAK RENEWAL MODELS H125 AND H120 WITH THE MODEL 2865 VERSION 1.8 APPLICATION SOFTWAREGuidant Corp.2004-01-26NKE
P030005186CONTAK RENEWAL MODELS H125 AND H120 WITH THE MODEL 2865 VERSION 1.8 APPLICATION SOFTWAREGuidant Corp.2004-01-26NKE
P030005201CONTAK RENEWAL MODELS H125 AND H120 WITH THE MODEL 2865 VERSION 1.8 APPLICATION SOFTWAREGuidant Corp.2004-01-26NKE
P030005210CONTAK RENEWAL MODELS H125 AND H120 WITH THE MODEL 2865 VERSION 1.8 APPLICATION SOFTWAREGuidant Corp.2004-01-26NKE
P030005220CONTAK RENEWAL MODELS H125 AND H120 WITH THE MODEL 2865 VERSION 1.8 APPLICATION SOFTWAREGuidant Corp.2004-01-26NKE
P030005223CONTAK RENEWAL MODELS H125 AND H120 WITH THE MODEL 2865 VERSION 1.8 APPLICATION SOFTWAREGuidant Corp.2004-01-26NKE
P030005225CONTAK RENEWAL MODELS H125 AND H120 WITH THE MODEL 2865 VERSION 1.8 APPLICATION SOFTWAREGuidant Corp.2004-01-26NKE
P030005237CONTAK RENEWAL MODELS H125 AND H120 WITH THE MODEL 2865 VERSION 1.8 APPLICATION SOFTWAREGuidant Corp.2004-01-26NKE
P030005240CONTAK RENEWAL MODELS H125 AND H120 WITH THE MODEL 2865 VERSION 1.8 APPLICATION SOFTWAREGuidant Corp.2004-01-26NKE
P030005246CONTAK RENEWAL MODELS H125 AND H120 WITH THE MODEL 2865 VERSION 1.8 APPLICATION SOFTWAREGuidant Corp.2004-01-26NKE
P030005250CONTAK RENEWAL MODELS H125 AND H120 WITH THE MODEL 2865 VERSION 1.8 APPLICATION SOFTWAREGuidant Corp.2004-01-26NKE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00802526559402PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00802526559402008025265594028025265594020802526559402

GMDN Terms#

Term, Definition table
TermDefinition
Cardiac resynchronization therapy implantable pacemakerA sterile, 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

Regulatory Flags#

DUNS number
106295384
Device count
1
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00191506062514Navigator™M0062504000M00625040002026-09-25
00191506062521Navigator™M0062504010M00625040102026-09-25
00191506062538Navigator™M0062504020M00625040202026-09-25
00191506062545Navigator™M0062504100M00625041002026-09-25
00191506062552Navigator™M0062504110M00625041102026-09-25
00191506062569Navigator™M0062504120M00625041202026-09-25
00191506062576Navigator™M0062504200M00625042002026-09-25
00191506062583Navigator™M0062504210M00625042102026-09-25
00191506062590Navigator™M0062504220M00625042202026-09-25
00802526531101ENDOTAK RELIANCE® S013701372014-09-24
00802526531118ENDOTAK RELIANCE® S013801382014-09-24
00802526531125ENDOTAK RELIANCE®015701572014-09-24
00802526531132ENDOTAK RELIANCE®015801582014-09-24
00191506047832NAM001AJAEC0100M001AJAEC01002026-09-22
00191506063214OPAL HDx™M004OPAL11020M004OPAL110202026-09-20
08714729972860LumiCoil™M005538302018-02-15
08714729972884LumiCoil™M005538402018-02-15
08714729842088Rhythmia™ Mapping SystemM004RH200002017-06-14
08714729842095Rhythmia™ Mapping SystemM004RH210002017-06-14
08714729842101Rhythmia™ Mapping SystemM004RH220002017-06-14

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Primary DI, Brand, Company table
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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
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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