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Boston Scientific Pty Ltd

Sponsor (Registration Holder) · 1347 devices on the TGA ARTG · 7 device classes · Jun 30, 2004Mar 21, 2025

1347
Total Devices
7
Device Classes
2004
Earliest
2025
Latest
Recent device registrations
Latest 10 TGA ARTG device registrations
Suture/ligature tightener, single-use
ARTG 483506
Class IIbMar 21, 2025
Manufacturer: Boston Scientific Corporation
Gastrointestinal suture anchor
ARTG 483505
Class IIbMar 21, 2025
Manufacturer: Boston Scientific Corporation
Vercise™ Cartesia™ HX Directional Lead Kit - Deep brain electrical stimulation system lead
ARTG 476409
Class IIIJan 22, 2025
Manufacturer: Boston Scientific Neuromodulation Corporation
Vercise™ Cartesia™ HX Directional Lead Kit - Deep brain electrical stimulation system lead
ARTG 476409
Class IIIJan 22, 2025
Manufacturer: Boston Scientific Neuromodulation Corporation
Vercise™ Cartesia™ X Directional Lead Kit - Deep brain electrical stimulation system lead
ARTG 476410
Class IIIJan 22, 2025
Manufacturer: Boston Scientific Neuromodulation Corporation
Vercise™ Cartesia™ X Directional Lead Kit - Deep brain electrical stimulation system lead
ARTG 476410
Class IIIJan 22, 2025
Manufacturer: Boston Scientific Neuromodulation Corporation
VersaCross Connect Access Solution for FARADRIVE - Transseptal access system
ARTG 474147
Class IIIDec 19, 2024
Manufacturer: Baylis Medical Company Inc
VersaCross Connect Access Solution for FARADRIVE - Transseptal access system
ARTG 474147
Class IIIDec 19, 2024
Manufacturer: Baylis Medical Company Inc
LUX-Dx Clinic Assistant Mobile Device - Implantable cardiac device management application software
ARTG 472725
Class IIIDec 11, 2024
Manufacturer: Cardiac Pacemakers Inc a subsidiary of Boston Scientific Corporation
myLUX Mobile Device - Implantable cardiac device management application software
ARTG 472726
Class IIIDec 11, 2024
Manufacturer: Cardiac Pacemakers Inc a subsidiary of Boston Scientific Corporation
Risk class distribution
Devices by risk class
Class I
154
11.4% of total
Class IIa
238
17.7% of total
Class IIb
217
16.1% of total
Class III
603
44.8% of total
Class Is
83
6.2% of total
Class Im
2
0.1% of total
AIMD
50
3.7% of total
About this profile

Explore comprehensive sponsor profile for Boston Scientific Pty Ltd through Pure Global AI's free Australia TGA ARTG medical device database. This company has sponsored 1347 medical devices registered with TGA ARTG across 7 device classes. Their sponsorship history spans from Jun 30, 2004 to Mar 21, 2025.

In Australia, the sponsor is the legal entity responsible for the medical device's compliance with TGA regulations and ARTG registration. This page provides detailed insights including recent device registrations, risk class distribution (Class III: 603, Class I: 154, Class IIb: 217, Class IIa: 238, Class Is: 83, AIMD: 50, Class Im: 2), and complete regulatory information from the official Australia TGA ARTG medical device database. Pure Global AI offers free access to Australia's complete medical device registry with 131,000+ devices.

Free Sponsor ProfilePowered by Pure Global AI1347 Devices7 Device Classes