Identity
- Trade Name
- Precision ™ FDA UDI
- Generic Name
- Trial spinal cord/peripheral nerve percutaneous analgesic electrical stimulation system pulse generator FDA UDI
- Device Name
- IR Interface FDA UDI
- Model / Reference
- SC-4500 FDA UDI
- Description
- IR Interface FDA UDI
Identifiers
- Catalog Number
- SC-4500 FDA UDI
- Primary DI / UDI-DI
- 08714729121770 FDA UDI
- PMA Number
- P030017 FDA UDI
- FDA Product Code
- LGW FDA UDIQRB 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
No
FDA UDI
Over-the-Counter
Yes
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
Precision ™ by Boston Scientific Neuromodulation — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
P030017 also covers:
- Artisan™ — Boston Scientific Neuromodulation
- 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 587fd601-f431-490b-82ff-d55126c63b7f 35 fields · synced Jun 8, 2026