Identity
- Trade Name
- OPTISURE™ FDA UDI
- Generic Name
- Endocardial defibrillation lead FDA UDI
- Device Name
- Defibrillation Lead FDA UDI
- Model / Reference
- LDA210Q-58 FDA UDI
- Description
- Defibrillation Lead FDA UDI
Identifiers
- Catalog Number
- LDA210Q-58 FDA UDI
- Primary DI / UDI-DI
- 05414734507325 FDA UDI
- PMA Number
- P950022 FDA UDI
- FDA Product Code
- NVY FDA UDI
- GMDN Term
- Endocardial defibrillation lead FDA UDI
Classification
- Device Class
- Class III 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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Conditional FDA UDI
Dimensions & Sizes
- Size
- Length — 58 Centimeter FDA UDI
Category: Endocardial defibrillation lead
Optisure™ by St. Jude Medical, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Endocardial defibrillation lead.
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- D2-Kit — BIOTRONIK SE & Co. KG · Class III
- ENDOTAK RELIANCE® SG — Boston Scientific · Class III
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- Sprint Quattro Secure S MRI™ SureScan™ — MEDTRONIC, INC. · Class III
Cleared under the same submission
P950022 also covers:
- Durata™ — ST. JUDE MEDICAL, INC.
- Durata™ — ST. JUDE MEDICAL, INC.
- Durata™ — ST. JUDE MEDICAL, INC.
- Durata™ — ST. JUDE MEDICAL, INC.
- Durata™ — ST. JUDE MEDICAL, INC.
- Durata™ — ST. JUDE MEDICAL, INC.
- Durata™ — ST. JUDE MEDICAL, INC.
- Durata™ — ST. JUDE MEDICAL, INC.
- Durata™ — ST. JUDE MEDICAL, INC.
- Durata™ — ST. JUDE MEDICAL, INC.
- Durata™ — ST. JUDE MEDICAL, INC.
- Durata™ — ST. JUDE MEDICAL, 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
- St. Jude Medical, Inc.
Sources (1)
- FDA UDI 08f47abe-d7ec-4e4e-8627-2ca2000c77e1 38 fields · synced May 30, 2026