Identity
- Trade Name
- N'VISION® FDA UDI
- Generic Name
- Multiple active implantable device programmer FDA UDI
- Device Name
- SFTWR 8870AAU01 N'VISION AAU/01 FDA UDI
- Model / Reference
- 8870AAU01 FDA UDI
- Description
- SFTWR 8870AAU01 N'VISION AAU/01 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00643169640863 FDA UDI
- PMA Number
- P860004 FDA UDI
- FDA Product Code
- LKK FDA UDI
- GMDN Term
- Multiple active implantable device programmer 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Multiple active implantable device programmer
N'vision® by Medtronic, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
P860004 also covers:
- ASCENDA® — MEDTRONIC, INC.
- ASCENDA® — MEDTRONIC, INC.
- ASCENDA® — MEDTRONIC, INC.
- ASCENDA® — MEDTRONIC, INC.
- ASCENDA® — MEDTRONIC, INC.
- Ascenda — MEDTRONIC, INC.
- Ascenda® — MEDTRONIC, INC.
- Ascenda® — MEDTRONIC, INC.
- Ascenda® — MEDTRONIC, INC.
- Ascenda® — MEDTRONIC, INC.
- Ascenda® — MEDTRONIC, INC.
- Ascenda® — 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 a971149c-8fe6-46b6-8beb-cb532b5ed528 36 fields · synced May 30, 2026