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Boston Scientific CoverEdge™ Surgical Lead Kit - HSA Registration DE0506536

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.

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CLASS D
DE0506536
Boston Scientific CoverEdge™ Surgical Lead Kit
HSA Registration Number: DE0506536
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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.

Device 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 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