Singapore HSA registration DE0506481
Boston Scientific Vercise DBS Lead Kits
Singapore·CLASS D·Boston Scientific Neuromodulation Corporation·Registered December 15, 2021Device classification
- Device Class
- CLASS D
- Medical Speciality Area
- Neurology
Registration information
- Registration Number
- DE0506481
- Registration Date
- December 15, 2021
- Change Notification Approval Date
- July 10, 2023
- Retention Due Date
- December 14, 2025
Product description
The Vercise™ standard 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.
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-2201-30DC 30 cm Lead Kit Model DB-2201-45DC 45Cm Lead Kit Model DB-2500-C Vercise™ Physician's Spare Kit Model DB-3128-55 55cm, 2x8 Contact Lead Extension Kit Model DB-3128-95 95cm, 2x8 Contact Lead Extension Kit Model DB-4100A O.R Cble and Extension Model DB-4120-08 8 Contact, Push Button OR Cable 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-5170 Vercise™ ETS 3 External Trial Stimulator 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)
- M365DB220130DC0 M365DB220145DC0 M365DB2500C0 M365DB3128550 M365DB3128950 M365DB4100A0 M365DB4120080 M365DB4600C0 M365DB4605C0 M365DB51320 M365DB51700 M365DB93150 M365NM3138550 M365SC42520 M365SC42540
About this record
Access comprehensive regulatory information for Boston Scientific Vercise DBS Lead Kits in the Singapore medical device market through Pure Global AI's free database. This CLASS D medical device is registered under HSA registration number DE0506481 and owned by Boston Scientific Neuromodulation Corporation. The device was registered on December 15, 2021.
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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