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Boston Scientific Vercise™ Cartesia™ DBS directional lead - HSA Registration DE0507684

Access comprehensive regulatory information for Boston Scientific Vercise™ Cartesia™ DBS directional lead in the Singapore medical device market through Pure Global AI's free database. This CLASS D medical device is registered under HSA registration number DE0507684 and owned by Boston Scientific Neuromodulation Corporation. The device was registered on January 13, 2023.

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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CLASS D
DE0507684
Boston Scientific Vercise™ Cartesia™ DBS directional lead
HSA Registration Number: DE0507684
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Product Description

The Vercise™ Cartesia™ Directional leads are part of the Vercise DBS Systems intended for: • 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. • Unilateral or bilateral stimulation of the subthalamic nucleus (STN) or internal globus pallidus (GPi) for 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.

Device Classification
Device Class
CLASS D
Medical Speciality Area
Neurology
Registration Information
Registration Number
DE0507684
Registration Date
January 13, 2023
Change Notification Approval Date
July 10, 2023
Retention Due Date
January 12, 2026
Product Owner
Short Name
Boston Scientific Neuromodulation Corporation
Address
25155 Rye Canyon Loop, Valencia CA 91355, UNITED STATES
Registrant
Address
9 NORTH BUONA VISTA DRIVE, THE METROPOLIS TOWER ONE, #20-01, SINGAPORE 138588
Importer
Address
9 NORTH BUONA VISTA DRIVE, THE METROPOLIS TOWER ONE, #20-01, SINGAPORE 138588
Model Information
Model Name(s)
Model DB-2202-30 Vercise™ Cartesia™ 30cm 8 Contact DBS Directional Lead Kit Model DB-2202-45 Vercise™ Cartesia™ 45cm 8 Contact DBS Directional Lead Kit Model DB-2500-C Vercise™ Physician's Spare Kit Model DB-4100A O.R. Cable and Extension Model DB-4600-C SureTek™ Burr Hole Cover Kit Model DB-4605-C SureTek™ Burr Hole Cover Spares Kit Model DB-5132 Vercise™ DBS External Trial Stimulator 2 Model DB-9315 Vercise(M) ETS Adapter Model NM-3138-55 55cm 8 Contact Extension Kit Model SC-4252 28cm Straw Tunneling Tool Model SC-4254 35cm Long Tunneling Tool
Model Identifier(s)
M365DB2202300 M365DB2202450 M365DB2500C0 M365DB4100A0 M365DB4600C0 M365DB4605C0 M365DB51320 M365DB93150 M365NM3138550 M365SC42520 M365SC42540