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Singapore HSA registration DE0507004

Boston Scientific Vercise™ Genus Implantable Pulse Generator System P Series

Singapore flagSingapore·CLASS D·Boston Scientific Neuromodulation Corporation·Registered June 23, 2022
Device classification
Device Class
CLASS D
Medical Speciality Area
Neurology
Registration information
Registration Number
DE0507004
Registration Date
June 23, 2022
Change Notification Approval Date
July 02, 2024
Retention Due Date
June 22, 2026
Product description
The Vercise Genus DBS System is an implantable Deep Brain Stimulation (DBS) system indicated for use in the following: • Unilateral or bilateral stimulation of the subthalamic nucleus (STN) or internal globus pallidus (Gpi) for levodopa-responsive Parkinson’s disease which is not adequately controlled with medication, for persons 18 years of age and older. • Unilateral or bilateral stimulation of the subthalamic nucleus (STN) or internal globus pallidus (GPi) for treatment of intractable primary and secondary dystonia, for persons 7 years of age and older. • Thalamic stimulation for the suppression of tremor not adequately controlled by medications in patients diagnosed with Essential Tremor or Parkinson’s disease, for persons 18 years of age and older.
Product Owner
Name
Boston Scientific Neuromodulation Corporation
Short Name
Boston Scientific Neuromodulation Corporation
Address
25155 Rye Canyon Loop, Valencia CA 91355, UNITED STATES
Registrant
Name
BOSTON SCIENTIFIC ASIA PACIFIC PTE. LTD.
Address
9 NORTH BUONA VISTA DRIVE, THE METROPOLIS TOWER ONE, #20-01, SINGAPORE 138588
Importer
Name
BOSTON SCIENTIFIC ASIA PACIFIC PTE. LTD.
Address
9 NORTH BUONA VISTA DRIVE, THE METROPOLIS TOWER ONE, #20-01, SINGAPORE 138588
Model information
Model Name(s)
Model DB-1416 Vercise Genus™ P16 Implantable Pulse Generator Kit Model DB-1432 Vercise Genus™P32 implantable Pulse Generator Kit Model DB-5270 Vercise DBS Remote Control 4 Model DB-5572-1A DBS Remote Control 4 Kit
Model Identifier(s)
M365DB14160 M365DB14320 M365DB52700 M365DB55721A0
About this record

Access comprehensive regulatory information for Boston Scientific Vercise™ Genus Implantable Pulse Generator System P Series in the Singapore medical device market through Pure Global AI's free database. This CLASS D medical device is registered under HSA registration number DE0507004 and owned by Boston Scientific Neuromodulation Corporation. The device was registered on June 23, 2022.

This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.

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