FDA.reportPublic FDA data

LATITUDE® NXT

Primary DI
00802526613876
Brand
LATITUDE® NXT
Company
BOSTON SCIENTIFIC CORPORATION
Model
6460
Catalog number
6460
Device description
Patient Management System
Published
2020-04-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
OSRPacemaker/icd/crt non-implanted components

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OSRPacemaker/Icd/Crt Non-Implanted ComponentsUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P910077176
P910077180
P910077185
P910077191
P910077194
P910077198

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P910077176VENTAK(R) PRX (TM) MODEL 1700,1705 PULSE GENERATORBoston Scientific1994-06-17LWS
P910077180VENTAK(R) PRX (TM) MODEL 1700,1705 PULSE GENERATORBoston Scientific1994-06-17LWS
P910077185VENTAK(R) PRX (TM) MODEL 1700,1705 PULSE GENERATORBoston Scientific1994-06-17LWS
P910077191VENTAK(R) PRX (TM) MODEL 1700,1705 PULSE GENERATORBoston Scientific1994-06-17LWS
P910077194VENTAK(R) PRX (TM) MODEL 1700,1705 PULSE GENERATORBoston Scientific1994-06-17LWS
P910077198VENTAK(R) PRX (TM) MODEL 1700,1705 PULSE GENERATORBoston Scientific1994-06-17LWS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00802526613876PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00802526613876008025266138768025266138760802526613876

GMDN Terms#

Term, Definition table
TermDefinition
Patient health record information system application softwareAn application software program, routines, and/or algorithms used as or in an information system to electronically receive, collect, store, manage, assist in analysis of, display, output, and distribute data, within or between healthcare facilities, to support the electronic registration and documentation of patient clinical data. It typically enables healthcare providers to review and update patient medical records, place orders (e.g., for medications, procedures, tests), and sometimes view multimedia data from many specialties. It is supplied for installation into a dedicated information system for patient health records, or existing mainframe or decentralized computers/networks.

Regulatory Flags#

DUNS number
106295384
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08714729893431ROTAPRO™ AdvancerH74939299A02018-07-11
08714729999560ROTAPRO™H749394671250H7493946712502020-07-01
08714729999577ROTAPRO™H749394671500H7493946715002020-07-01
08714729999584ROTAPRO™H749394671750H7493946717502020-07-01
08714729999591ROTAPRO™H749394672000H7493946720002020-07-01
08714729999607ROTAPRO™H749394672150H7493946721502020-07-01
08714729999614ROTAPRO™H749394672250H7493946722502020-07-01
08714729999621ROTAPRO™H749394672380H7493946723802020-07-01
08714729999638ROTAPRO™H749394672500H7493946725002020-07-01
00191506062620RIVOS™M00553900M005539002026-06-25
08714729050650Entry KitM001503500M0015035002016-01-29
08714729082026SteeroCath-Dx™M0042028BL02016-09-24
08714729085249Electrophysiology CableM00490002016-09-24
08714729114659Greenfield™M001503000M0015030002015-09-24
08714729114666Greenfield™M001503010M0015030102015-09-24
08714729124993Greenfield™M001505010M0015050102015-09-24
08714729270249Electrophysiology CableM004901AS02016-09-24
08714729270256Electrophysiology CableM004901BS02016-09-24
08714729334996Electrophysiology CableM004921B02016-09-24
08714729335009Electrophysiology CableM004921P02016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04035479190538SW HMSC 3.66BIOTRONIK SE & Co. KGOSR2026-05-28
00802526628900LATITUDE™ Programming SystemBOSTON SCIENTIFIC CORPORATIONOSR2026-05-14
00802526627903LATITUDE™ Programming SystemBOSTON SCIENTIFIC CORPORATIONOSR2026-01-21
04035479189235SW HMSC 3.65BIOTRONIK SE & Co. KGOSR2026-01-20
04035479189044SW HMSC 3.64BIOTRONIK SE & Co. KGOSR2025-10-16
00802526625206LATITUDE™ Programming SystemBOSTON SCIENTIFIC CORPORATIONOSR2025-06-26
05415067049575Merlin™ST. JUDE MEDICAL, INC.OSR2025-06-25
04035479188689SW HMSC 3.63BIOTRONIK SE & Co. KGOSR2025-05-07
00763000812058NAMEDTRONIC, INC.OSR2025-04-12
04035479187927SW HMSC 3.62BIOTRONIK SE & Co. KGOSR2025-01-20
04035479188399NEO 2401.U/1BIOTRONIK SE & Co. KGOSR2024-12-18
05415067034809Merlin@home™ST. JUDE MEDICAL, INC.OSR2024-11-13
04035479176143Home Monitoring Service CenterBIOTRONIK SE & Co. KGOSR2024-09-20
04035479187163Home Monitoring Service CenterBIOTRONIK SE & Co. KGOSR2024-09-03
04035479186005NEOBIOTRONIK SE & Co. KGOSR2024-06-17
04035479186012PSWBIOTRONIK SE & Co. KGOSR2024-06-17
04035479186128Home Monitoring Service CenterBIOTRONIK SE & Co. KGOSR2024-05-29
00763000378356Instrument Command LibraryMEDTRONIC, INC.OSR2024-05-04
00763000378363Device Command LibraryMEDTRONIC, INC.OSR2024-05-04
04035479184636Home Monitoring Service CenterBIOTRONIK SE & Co. KGOSR2024-01-10
04035479184285NEOBIOTRONIK SE & Co. KGOSR2023-12-15
04035479184292PSWBIOTRONIK SE & Co. KGOSR2023-12-15
04035479185510Renamic Neo NEOexpressBIOTRONIK SE & Co. KGOSR2023-12-15
00763000842536NAMEDTRONIC, INC.OSR2023-11-11
00802526622601LATITUDE™ Programming SystemBOSTON SCIENTIFIC CORPORATIONOSR2023-10-27
00802526622908LATITUDE™ Programming SystemBOSTON SCIENTIFIC CORPORATIONOSR2023-10-27
04035479183264Home Monitoring Service CenterBIOTRONIK SE & Co. KGOSR2023-10-13
04035479182960NEOBIOTRONIK SE & Co. KGOSR2023-08-23
04035479182977PSWBIOTRONIK SE & Co. KGOSR2023-08-23
04035479179632PSWBIOTRONIK SE & Co. KGOSR2023-08-15