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WaveWriter Alpha™

FDA UDI

Class III (US FDA UDI)

by Boston Scientific Neuromodulation

Identity

Trade Name
WaveWriter Alpha™ FDA UDI
Generic Name
Trial spinal cord/peripheral nerve percutaneous analgesic electrical stimulation system pulse generator FDA UDI
Device Name
Patient Trial Kit FDA UDI
Model / Reference
SC-6500-72 FDA UDI
Description
Patient Trial Kit FDA UDI

Identifiers

Primary DI / UDI-DI
08714729995241 FDA UDI
PMA Number
P030017 FDA UDI
FDA Product Code
QRB FDA UDI
LGW FDA UDI
GMDN Term
Trial spinal cord/peripheral nerve percutaneous analgesic electrical stimulation system pulse generator FDA UDI

Classification

Device Class
Class III FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Trial spinal cord/peripheral nerve percutaneous analgesic electrical stimulation system pulse generator

WaveWriter Alpha™ by Boston Scientific Neuromodulation — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Trial spinal cord/peripheral nerve percutaneous analgesic electrical stimulation system pulse generator.

Cleared under the same submission

P030017 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Boston Scientific Neuromodulation

Sources (1)

  • FDA UDI 90a86954-46f9-44f4-9de1-93c4955ebe01 34 fields · synced Jun 8, 2026