Identity
- Trade Name
- Assess Review ™ FDA UDI
- Generic Name
- Multiple active implantable device programmer FDA UDI
- Device Name
- PROG 7438 SOLETRA EZ PATIENT US FDA UDI
- Model / Reference
- 7438 FDA UDI
- Description
- PROG 7438 SOLETRA EZ PATIENT US FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00613994808349 FDA UDI
- PMA Number
- P960009 FDA UDI
- FDA Product Code
- OLM FDA UDIMRU FDA UDIMHY FDA UDIMFR FDA UDINHL FDA UDIPJS FDA UDI
- GMDN Term
- Multiple active implantable device programmer FDA UDI
Classification
- Device Class
- Unclassified 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
Assess Review ™ by Medtronic, Inc. — Class Unclassified — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
P960009 also covers:
- Activa® PC — MEDTRONIC, INC.
- Activa® RC — MEDTRONIC, INC.
- Activa® RC — MEDTRONIC, INC.
- Assess ® — MEDTRONIC, INC.
- DBS™ — MEDTRONIC, INC.
- DBS™ — MEDTRONIC, INC.
- Intercept ™ — MEDTRONIC, INC.
- N'VISION 8840 — MEDTRONIC, INC.
- Percept™ PC BrainSense™ — MEDTRONIC, INC.
- SenSight™ — MEDTRONIC, INC.
- SenSight™ — MEDTRONIC, INC.
- SenSight™ — 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 Unclassified | Pending data |
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Manufacturer
- Manufacturer
- Medtronic, Inc.
Sources (1)
- FDA UDI 5997f3d9-149d-442c-811d-abaef1b41dc7 35 fields · synced Jun 8, 2026