FDA.reportPublic FDA data

LATITUDE™ Programming System

Primary DI
00802526622908
Brand
LATITUDE™ Programming System
Company
BOSTON SCIENTIFIC CORPORATION
Model
623300-112
Catalog number
623300-112
Device description
Programming System
Published
2023-10-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

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
P910077169
P910077186
P910077187
P910077193

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P910077169VENTAK(R) PRX (TM) MODEL 1700,1705 PULSE GENERATORBoston Scientific1994-06-17LWS
P910077186VENTAK(R) PRX (TM) MODEL 1700,1705 PULSE GENERATORBoston Scientific1994-06-17LWS
P910077187VENTAK(R) PRX (TM) MODEL 1700,1705 PULSE GENERATORBoston Scientific1994-06-17LWS
P910077193VENTAK(R) PRX (TM) MODEL 1700,1705 PULSE GENERATORBoston Scientific1994-06-17LWS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00802526622908PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00802526622908008025266229088025266229080802526622908

GMDN Terms#

Term, Definition table
TermDefinition
Cardiac pulse generator programmerAn external device intended to enable a healthcare professional in a clinical setting to noninvasively change the settings of, and extract data from, an implanted cardiac pulse generator (e.g., pacemaker, pacemaker/defibrillator). It includes a radio-frequency transmitter/receiver and may be intended to operate independently or in conjunction with a personal computer (PC)/tablet using dedicated software.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
106295384
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00802526625008ACUITY™706070602026-10-15
08714729748861RX Cholangiogram KitM005711502016-09-24
08714729748878RX Cholangiogram KitM005711602016-09-24
08714729749097RX Cholangiogram KitM005714002016-09-24
08714729749110RX Cholangiogram KitM005714202016-09-24
08714729749257RX Cholangiogram KitM005715602016-09-24
08714729749295RX Cholangiogram KitM005716002016-09-24
08714729749332RX Cholangiogram KitM005716402016-09-24
08714729749394RX Cholangiogram KitM005717002016-09-24
08714729749509RX Cholangiogram KitM005718102016-09-24
08714729749615RX Cholangiogram KitM005719202016-09-24
00191506065577Ranger™H74939501400470H749395014004702026-10-14
00191506065584Ranger™H74939501400670H749395014006702026-10-14
00191506065591Ranger™H74939501400870H749395014008702026-10-14
00191506065607Ranger™H74939501401070H749395014010702026-10-14
00191506065614Ranger™H74939501401270H749395014012702026-10-14
00191506065621Ranger™H74939501401570H749395014015702026-10-14
00191506065638Ranger™H74939501402070H749395014020702026-10-14
00191506065645Ranger™H74939501400410H749395014004102026-10-14
00191506065652Ranger™H74939501400610H749395014006102026-10-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04035479194406SW HMSC 3.68BIOTRONIK SE & Co. KGOSR2026-10-09
04035479190705NEO 2601.UBIOTRONIK SE & Co. KGOSR2026-09-21
04035479190712PSW 2601.UBIOTRONIK SE & Co. KGOSR2026-09-21
00763000862336MyCareLink™MEDTRONIC, INC.OSR2026-07-26
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
04035479183264Home Monitoring Service CenterBIOTRONIK SE & Co. KGOSR2023-10-13