FDA.reportPublic FDA data

LUX-Dx™ Insertable Cardiac Monitor

Primary DI
00802526607103
Brand
LUX-Dx™ Insertable Cardiac Monitor
Company
BOSTON SCIENTIFIC CORPORATION
Model
M301
Catalog number
60M301-102
Device description
LUX-Dx™ Insertable Cardiac Monitor
Published
2020-07-01
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
MXDRecorder, event, implantable cardiac, (with arrhythmia detection)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MXDRecorder, Event, Implantable Cardiac, (With Arrhythmia Detection)Cardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K193473000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K193473000LUX-Dx Insertable Cardiac Monitor, myLUX Software Mobile Application, LUX-Dx Clinic Assistant Software, Application Server Device Services (DS) - USBoston Scientific Corporation2020-06-26MXD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00802526607103PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00802526607103008025266071038025266071030802526607103

GMDN Terms#

Term, Definition table
TermDefinition
Implantable cardiac monitorA hermetically-sealed, electrically-powered device [an implantable cardiac monitor (ICM)] intended to be implanted to monitor, record, and store electrocardiographic signals to help diagnose and monitor cardiac arrhythmias and/or acute coronary syndrome (ACS) changes; it may have a vibratory alarm function and the data can be telemetrically transmitted to an external device for alarming the patient and/or remote data transmission. It is used for a patient who experiences unexplained cardiac-related symptoms and/or is at risk for cardiac arrhythmias and/or ACS events.

Sterilization Methods#

Method table
Method

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08714729972860LumiCoil™M005538302018-02-15
08714729972884LumiCoil™M005538402018-02-15
08714729842088Rhythmia™ Mapping SystemM004RH200002017-06-14
08714729842095Rhythmia™ Mapping SystemM004RH210002017-06-14
08714729842101Rhythmia™ Mapping SystemM004RH220002017-06-14
08714729880318Rhythmia™ Mapping SystemM004RBLMR1002016-09-24
08714729938736RHYTHMIA HDx™M004RH20010M004RH200102017-05-03
08714729832089Rubicon™ 18H749392390180902016-09-24
08714729832096Rubicon™ 35H749392400350902016-09-24
08714729832102Rubicon™ 35H749392400351502016-09-24
08714729832119Rubicon™ 35H749392400350602016-09-24
08714729832126Rubicon™ 35H749392400351302016-09-24
08714729832133Rubicon™ 14H749392120141302016-09-24
08714729832140Rubicon™ 14H749392120141502016-09-24
08714729832157Rubicon™ 18H749392390181302016-09-24
08714729832164Rubicon™ 18H749392390181502016-09-24
00191506019563Rubicon™ ControlH749394321409A0H749394321409A02024-02-16
00191506019587Rubicon™ ControlH749394321413A0H749394321413A02024-02-16
00191506019600Rubicon™ ControlH749394321415A0H749394321415A02024-02-16
00191506019624Rubicon™ ControlH749394321809A0H749394321809A02024-02-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05415067055095Assert-IQ™ST. JUDE MEDICAL, INC.MXD2026-01-05
05415067053275Merlin.net™ST. JUDE MEDICAL, INC.MXD2025-10-21
00802526618208myLUX™ Patient AppBOSTON SCIENTIFIC CORPORATIONMXD2025-04-11
00802526618215myLUX™ Patient AppBOSTON SCIENTIFIC CORPORATIONMXD2025-04-11
00802526625404LUX-Dx™BOSTON SCIENTIFIC CORPORATIONMXD2024-09-30
00763000754914CareLink SmartSync™ LINQ II™ Insertable Cardiac Monitor (ICM) ApplicationMEDTRONIC, INC.MXD2024-04-25
00763000891091CareLink SmartSync™ LINQ II™ Platform ApplicationMEDTRONIC, INC.MXD2024-04-25
00802526621017LUX-Dx™ Clinic Assistant Mobile DeviceBOSTON SCIENTIFIC CORPORATIONMXD2023-12-14
00763000613747LINQ II™MEDTRONIC, INC.MXD2023-11-19
00802526621000myLUX™ Mobile DeviceBOSTON SCIENTIFIC CORPORATIONMXD2023-09-08
00802526620706LUX-Dx II+™BOSTON SCIENTIFIC CORPORATIONMXD2023-08-31
00802526620713LUX-Dx II™BOSTON SCIENTIFIC CORPORATIONMXD2023-08-31
00802526621307myLUX™BOSTON SCIENTIFIC CORPORATIONMXD2023-08-31
00802526623103myLUX™ Patient AppBOSTON SCIENTIFIC CORPORATIONMXD2023-08-31
00802526623110myLUX™ Patient AppBOSTON SCIENTIFIC CORPORATIONMXD2023-08-31
04035479177850BioMonitor IVBIOTRONIK SE & Co. KGMXD2023-05-24
00763000504519AccuRhythm™ AIMEDTRONIC, INC.MXD2021-12-31
00763000504526AccuRhythm™ AIMEDTRONIC, INC.MXD2021-12-31
00763000504533AccuRhythm™ AIMEDTRONIC, INC.MXD2021-12-31
00763000562625Reveal LINQ™MEDTRONIC, INC.MXD2021-09-04
00763000562632Reveal LINQ™MEDTRONIC, INC.MXD2021-09-04
00763000554002LINQ II™MEDTRONIC, INC.MXD2021-06-14
00763000060374LINQ II™MEDTRONIC, INC.MXD2020-07-18
00763000162191LINQ II™MEDTRONIC, INC.MXD2020-07-18
00802526607363myLUX™ Patient Kit with mobile deviceBOSTON SCIENTIFIC CORPORATIONMXD2020-07-01
00802526607370LUX-Dx™ Clinic Assistant Kit with mobile deviceBOSTON SCIENTIFIC CORPORATIONMXD2020-07-01
00802526607608myLUX™ patient appBOSTON SCIENTIFIC CORPORATIONMXD2020-07-01
00802526607615LUX-Dx™ Clinic Assistant appBOSTON SCIENTIFIC CORPORATIONMXD2020-07-01
00802526613838LATITUDE® ClarityBOSTON SCIENTIFIC CORPORATIONMXD2020-07-01
04035479169862BioMonitor IIImBIOTRONIK SE & Co. KGMXD2020-05-06