Identity
- Trade Name
- CAPSURE®SP NOVUS FDA UDI
- Generic Name
- Endocardial/interventricular septal pacing lead FDA UDI
- Device Name
- LEAD 559458 CAPSURE SP US BI SIL ATRL FDA UDI
- Model / Reference
- 559458 FDA UDI
- Description
- LEAD 559458 CAPSURE SP US BI SIL ATRL FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00643169590762 FDA UDI
- PMA Number
- P850089 FDA UDI
- FDA Product Code
- NVN FDA UDIDTB FDA UDINVY 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
Single Use
Yes
Implantable
Yes
Contains Latex
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
Yes
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
No
Dimensions & Sizes
- Size
- Length — 58.0 Centimeter FDA UDI
Category: Endocardial/interventricular septal pacing lead
For patients with a pacemaker, the CAPSURE SP Novus is an implantable wire electrode that enables continuous cardiac pacing. This device features a non-conductive insulation material at its ends, which allows for the transmission of pacing impulses from an implanted pulse generator to the heart. The electrode end is typically placed through a vein or pierced into the myocardium adjacent to the His-Purkinje system, while the other end connects to the pulse generator.
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Authorization Coverage (1 country)
Regulatory Authorizations
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 c0905f72-f5cb-49ee-9607-9361cee2cf2b 37 fields · synced Jun 27, 2026