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Singapore HSA registration DE0507926

Boston Scientific Avista™ MRI 8 Contact Lead Kit

Singapore flagSingapore·CLASS D·Boston Scientific Neuromodulation Corporation·Registered March 22, 2023
Device classification
Device Class
CLASS D
Medical Speciality Area
Neurology
Registration information
Registration Number
DE0507926
Registration Date
March 22, 2023
Retention Due Date
March 21, 2026
Product description
Leads function as a component of 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
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 SC-2408-56 Avista MRI Percutaneous Lead Kit, 56cm Model SC-2408-74 Avista MRI Percutaneous Lead Kit, 74cm Model SC-4319 Clik X MRI Anchor Model SC-4395-56 Enhanced Steering Kit with Stylet Cap 56cm Model SC-4395-74 Enhanced Steering Kit with Stylet Cap 74cm
Model Identifier(s)
M365SC2408560 M365SC2408740 M365SC43190 M365SC4395560 M365SC4395740
About this record

Access comprehensive regulatory information for Boston Scientific Avista™ MRI 8 Contact 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 DE0507926 and owned by Boston Scientific Neuromodulation Corporation. The device was registered on March 22, 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.

Free DatabasePowered by Pure Global AIHSA Official DataCLASS D