Identity
- Trade Name
- CapSure Sense MRI™ SureScan™ FDA UDI
- Generic Name
- Endocardial/interventricular septal pacing lead FDA UDI
- Device Name
- LEAD 407458 MRI US BI RCMRCD FDA UDI
- Model / Reference
- 407458 FDA UDI
- Description
- LEAD 407458 MRI US BI RCMRCD FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00643169448957 FDA UDI
- PMA Number
- P830061 FDA UDI
- FDA Product Code
- NVN FDA UDINVY FDA UDIDTB FDA UDI
- GMDN Term
- Endocardial/interventricular septal pacing lead FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Regulation Number
- 870.3680 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
Yes
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
Dimensions & Sizes
- Size
- Length — 58.0 Centimeter FDA UDI
Category: Endocardial/interventricular septal pacing lead
CapSure Sense MRI™ 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
P830061 also covers:
- CapSure Sense MRI™ SureScan™ — MEDTRONIC, INC.
- CapSure Sense MRI™ SureScan™ — MEDTRONIC, INC.
- CapSure Sense MRI™ SureScan™ — MEDTRONIC, INC.
- CapSure Sense MRI™ SureScan™ — MEDTRONIC, INC.
- CapSure Sense MRI™ SureScan™ — MEDTRONIC, INC.
- CapSure Sense MRI™ SureScan™ — MEDTRONIC, INC.
- CapSure Sense MRI™ 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 d50b8627-03e2-46d6-99ba-9fb61c0250ff 37 fields · synced Jun 6, 2026