Identity
- Trade Name
- Precision ® Patient Controller FDA UDI
- Generic Name
- Analgesic spinal cord electrical stimulation system FDA UDI
- Device Name
- Precision ® Patient Controller FDA UDI
- Model / Reference
- SC-5400 FDA UDI
- Description
- Precision ® Patient Controller FDA UDI
Identifiers
- Catalog Number
- SC-5400 FDA UDI
- Primary DI / UDI-DI
- M365SC54000 FDA UDI
- PMA Number
- P030017 FDA UDI
- FDA Product Code
- LGW FDA UDI
- GMDN Term
- Analgesic spinal cord electrical stimulation system 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: Analgesic spinal cord electrical stimulation system
Precision ® Patient Controller by Boston Scientific Neuromodulation — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Analgesic spinal cord electrical stimulation system.
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Cleared under the same submission
P030017 also covers:
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- Artisan™ — Boston Scientific Neuromodulation
- Bionic Navigator™ 3D — Boston Scientific Neuromodulation
- Bionic Navigator™ 3D — Boston Scientific Neuromodulation
- Clik™ Anchor — Boston Scientific Neuromodulation
- Clik™ Anchor — Boston Scientific Neuromodulation
- Entrada ™ — Boston Scientific Neuromodulation
- Freelink™ — Boston Scientific Neuromodulation
- Infinion™ 16 — Boston Scientific Neuromodulation
- Infinion™ CX — Boston Scientific Neuromodulation
- Linear ST ™ — Boston Scientific Neuromodulation
- Linear ™ — Boston Scientific Neuromodulation
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Boston Scientific Neuromodulation
Sources (1)
- FDA UDI 2c707615-bb01-41d4-8d6f-77688dd72aaa 34 fields · synced May 30, 2026