WaveWriter Alpha™ Prime

GUDID 08714729985075

Implantable Pulse Generator Kit

BOSTON SCIENTIFIC NEUROMODULATION CORPORATION

Analgesic spinal cord electrical stimulation system pulse generator, implantable

• Primary Device ID: 08714729985075
• NIH Device Record Key: 3f5ffdf0-1b77-4fe0-ad0c-d4a95a9fbabc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: WaveWriter Alpha™ Prime
• Version Model Number: SC-1432
• Company DUNS: 824951958
• Company Name: BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08714729985075 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P030017

FDA Product Code

• LGW: Stimulator, spinal-cord, totally implanted for pain relief
• QRB: Stimulator, spinal-cord, totally implanted for relief of pain due to diabetic neuropathy

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-01-05
• Device Publish Date: 2020-12-28

Devices Manufactured by BOSTON SCIENTIFIC NEUROMODULATION CORPORATION

• 08714729121466 - Precision™: 2026-01-19 Suture Sleeve
• 08714729121473 - Precision™: 2026-01-19 Suture Sleeve 2.3cm Tapered
• 08714729121480 - Precision™: 2026-01-19 Suture Sleeve 4cm Segmented
• 08714729767572 - Precision ™: 2026-01-19 Passing Elevator
• 08714729767626 - Precision™: 2026-01-19 Suture Sleeve 2.3cm Split
• 08714729767756 - Precision™: 2026-01-19 Suture Sleeve 1cm Split
• 08714729767763 - Precision™: 2026-01-19 Suture Sleeve 4cm Split
• 08714729905318 - Clik™ X: 2025-12-17 Anchor