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Boston Scientific WaveWriter Alpha™ Prime Implantable Pulse Generators - HSA Registration DE0507121

Access comprehensive regulatory information for Boston Scientific WaveWriter Alpha™ Prime Implantable Pulse Generators in the Singapore medical device market through Pure Global AI's free database. This CLASS D medical device is registered under HSA registration number DE0507121 and owned by Boston Scientific Neuromodulation Corporation. The device was registered on July 28, 2022.

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
DE0507121
Boston Scientific WaveWriter Alpha™ Prime Implantable Pulse Generators
HSA Registration Number: DE0507121
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Product Description

The Boston Scientific WaveWriter Alpha™ Prime Implantable Pulse Generators are indicated for use in spinal cord stimulation and in the stimulation of the peripheral nerves of the trunk as an aid in the management of chronic intractable pain.

Device Classification
Device Class
CLASS D
Medical Speciality Area
Neurology
Registration Information
Registration Number
DE0507121
Registration Date
July 28, 2022
Change Notification Approval Date
February 06, 2025
Retention Due Date
July 27, 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-1416 WaveWriter Alpha™ Prime 16 Implantable Generator Kit Model SC-1432 WaveWriter Alpha™ Prime Implantable Generator Kit Model SC-5270 Freelink™ Remote Control Model SC-5572-1A Freelink™ Remote Control Kit Model SC-6305 Charger Power Supply Model SC-6350 Adhesive Kit Model SC-6386 Pairing Magnet Model SC-9208-15 Precision S8 Adapter - 15cm Model SC-9208-55 Precision S8 Adapter - 55cm Model SC-9218-15 Precision M8 Adapter - 15 cm Model SC-9218-55 Precision M8 Adapter - 55cm
Model Identifier(s)
M365SC14160 M365SC14320 M365SC52700 M365SC55721A0 M365SC63050 M365SC63500 M365SC63860 M365SC9208150 M365SC9208550 M365SC9218150 M365SC9218550