Identity
- Trade Name
- Tendril™ FDA UDI
- Generic Name
- Endocardial/interventricular septal pacing lead FDA UDI
- Device Name
- Pacing Lead FDA UDI
- Model / Reference
- ST FDA UDI
- Description
- Pacing Lead FDA UDI
Identifiers
- Catalog Number
- 1888TC-58 FDA UDI
- Primary DI / UDI-DI
- 05414734501705 FDA UDI
- PMA Number
- P960013 FDA UDI
- FDA Product Code
- NVY FDA UDI
- GMDN Term
- Endocardial/interventricular septal pacing 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
Yes
FDA UDI
Dimensions & Sizes
- Size
- Length — 58 Centimeter FDA UDI
Category: Endocardial/interventricular septal pacing lead
Tendril™ by St. Jude Medical, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
P960013 also covers:
- Locator™ — ST. JUDE MEDICAL, INC.
- Locator™ — ST. JUDE MEDICAL, INC.
- Locator™ — ST. JUDE MEDICAL, INC.
- Locator™ — ST. JUDE MEDICAL, INC.
- Locator™ — ST. JUDE MEDICAL, INC.
- Locator™ — ST. JUDE MEDICAL, INC.
- Optisense™ — ST. JUDE MEDICAL, INC.
- Optisense™ — ST. JUDE MEDICAL, INC.
- Optisense™ — ST. JUDE MEDICAL, INC.
- Tendril™ — ST. JUDE MEDICAL, INC.
- Tendril™ — ST. JUDE MEDICAL, INC.
- Tendril™ — 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 a2a6670f-e888-4c9a-a837-aa32dc31e443 38 fields · synced Jun 1, 2026