Identity
- Trade Name
- Intellis™ FDA UDI
- Generic Name
- Spinal cord/peripheral nerve implantable analgesic electrical stimulation system pulse generator, implantable FDA UDI
- Device Name
- INS 97716 INTELLIS US EMANUAL FDA UDI
- Model / Reference
- 97716 FDA UDI
- Description
- INS 97716 INTELLIS US EMANUAL FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00763000315474 FDA UDI
- PMA Number
- P840001 FDA UDI
- FDA Product Code
- LGW FDA UDI
- GMDN Term
- Spinal cord/peripheral nerve implantable analgesic electrical stimulation system pulse generator, implantable FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Conditional FDA UDI
Intellis™ by Medtronic, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
P840001 also covers:
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- PISCES-QUAD® — MEDTRONIC, INC.
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- Specify® SureScan® — MEDTRONIC, INC.
- Specify® SureScan® MRI 5-6-5 — MEDTRONIC, INC.
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 |
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Manufacturer
- Manufacturer
- Medtronic, Inc.
Sources (1)
- FDA UDI 32e523dc-651c-4a8f-bc27-04d2924be689 36 fields · synced Jun 1, 2026