Identity
- Trade Name
- RestoreAdvanced® SureScan® FDA UDI
- Generic Name
- Spinal cord/peripheral nerve implantable analgesic electrical stimulation system pulse generator, implantable FDA UDI
- Device Name
- INS 97713 RESTORE ADVANCED MRICS FDA UDI
- Model / Reference
- 97713 FDA UDI
- Description
- INS 97713 RESTORE ADVANCED MRICS FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00643169109490 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
RestoreAdvanced® SureScan® 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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- Injex® — MEDTRONIC, INC.
- Intellis™ — MEDTRONIC, INC.
- Itrel® — MEDTRONIC, INC.
- Itrel® EZ — MEDTRONIC, INC.
- N'VISION® — MEDTRONIC, INC.
- N'VISION 8840 — MEDTRONIC, INC.
- PISCES-QUAD PLUS ™ — MEDTRONIC, INC.
- PISCES-QUAD PLUS ™ — MEDTRONIC, INC.
- PISCES-QUAD® — MEDTRONIC, INC.
- RESUME ® TL — MEDTRONIC, INC.
- Specify® SureScan® — 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 03a0728d-7c05-4649-8b1c-33501b74fec8 36 fields · synced Jun 8, 2026