Singapore HSA registration DE0506536
Boston Scientific CoverEdge™ Surgical Lead Kit
Singapore·CLASS D·Boston Scientific Neuromodulation Corporation·Registered December 30, 2021Device classification
- Device Class
- CLASS D
- Medical Speciality Area
- Neurology
Registration information
- Registration Number
- DE0506536
- Registration Date
- December 30, 2021
- Change Notification Approval Date
- October 28, 2022
- Retention Due Date
- December 29, 2025
Product description
The surgical Paddle Leads function as a component of Boston Scientific's Spinal Cord Stimulator (SCS) systems by delivering electrical stimulation to the nerve structures in the dorsal aspect of the spinal cord, resulting in an inhibition of pain sensation.
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 SC-4231-36 CoverEdge Paddle Blank (Tight Spacing) Model SC-4231-52 CoverEdge X Paddle Blank (Wide Spacing) Model SC-4318 Clik X Anchor Model SC-5170 WaveWriter Alpha™ External Trial Stimulator Model SC-6360-72 Patient Trial Belt Model SC-6500-72A WaveWrite Alpha™ Patient Trial Kit Model SC-8336-50 Cover Edge, 50cm Model SC-8336-70 Cover Edge, 70cm Model SC-8352-50 Cover Edge X, 50cm Model SC-8352-70 CoverEdge X 70cm Wide Spacing
- Model Identifier(s)
- M365SC4231360 M365SC4231520 M365SC43180 M365SC51700 M365SC6360720 M365SC650072A0 M365SC8336500 M365SC8336700 M365SC8352500 M365SC8352700
About this record
Access comprehensive regulatory information for Boston Scientific CoverEdge™ Surgical Lead Kit in the Singapore medical device market through Pure Global AI's free database. This CLASS D medical device is registered under HSA registration number DE0506536 and owned by Boston Scientific Neuromodulation Corporation. The device was registered on December 30, 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.
Free DatabasePowered by Pure Global AIHSA Official DataCLASS D