Identity
- Trade Name
- INTERSTIM FDA UDI
- Generic Name
- Sacral plexus implantable incontinence-control electrical stimulation system electrode FDA UDI
- Device Name
- LEAD 3889-33 TINED QUAD SNS US FDA UDI
- Model / Reference
- 3889-33 FDA UDI
- Description
- LEAD 3889-33 TINED QUAD SNS US FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00613994601964 FDA UDI
- PMA Number
- P970004 FDA UDI
- FDA Product Code
- EZW FDA UDI
- GMDN Term
- Sacral plexus implantable incontinence-control electrical stimulation system electrode FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Regulation Number
- 876.5270 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Length — 33.0 Centimeter FDA UDI
Category: Sacral plexus implantable incontinence-control electrical stimulation system electrode
Interstim by Medtronic, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
P970004 also covers:
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- INTERSTIM® — MEDTRONIC, INC.
- INTERSTIM® — MEDTRONIC, INC.
- INTERSTIM® — MEDTRONIC, INC.
- INTERSTIM® — MEDTRONIC, INC.
- INTERSTIM® — MEDTRONIC, INC.
- INTERSTIM® — MEDTRONIC, INC.
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- InterStim™ — MEDTRONIC, INC.
- InterStim™ — MEDTRONIC, INC.
- InterStim™ — 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 8a52bae6-0e85-4207-8490-3b208f8b873a 36 fields · synced May 31, 2026