Identity
- Trade Name
- Tendyne™ FDA UDI
- Generic Name
- Mitral transcatheter heart valve bioprosthesis FDA UDI
- Device Name
- Mitral Valve FDA UDI
- Model / Reference
- TENDV-LP-33M FDA UDI
- Description
- Mitral Valve FDA UDI
Identifiers
- Catalog Number
- TENDV-LP-33M FDA UDI
- Primary DI / UDI-DI
- 05415067032607 FDA UDI
- PMA Number
- P240042 FDA UDI
- FDA Product Code
- NPU FDA UDI
- GMDN Term
- Mitral transcatheter heart valve bioprosthesis 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
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Conditional FDA UDI
Category: Mitral transcatheter heart valve bioprosthesis
Tendyne™ by St. Jude Medical, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Mitral transcatheter heart valve bioprosthesis.
- SAPIEN 3 Ultra RESILIA — Edwards Lifesciences LLC · Class III
- EDWARDS CERTITUDE INTRODUCER SHEATH SET — Edwards Lifesciences LLC · Class III
- SAPIEN 3 Ultra Delivery System — Edwards Lifesciences LLC · Class III
- Edwards Certitude Delivery System — Edwards Lifesciences LLC · Class III
- SAPIEN 3 Ultra RESILIA — Edwards Lifesciences LLC · Class III
- Edwards Certitude Delivery System — Edwards Lifesciences LLC · Class III
- Edwards Certitude Delivery System — Edwards Lifesciences LLC · Class III
- EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE (THV) — Edwards Lifesciences LLC · Class III
Cleared under the same submission
P240042 also covers:
- Tendyne™ — ST. JUDE MEDICAL, INC.
- Tendyne™ — ST. JUDE MEDICAL, INC.
- Tendyne™ — ST. JUDE MEDICAL, INC.
- Tendyne™ — ST. JUDE MEDICAL, INC.
- Tendyne™ — ST. JUDE MEDICAL, INC.
- Tendyne™ — ST. JUDE MEDICAL, INC.
- Tendyne™ — ST. JUDE MEDICAL, INC.
- Tendyne™ — ST. JUDE MEDICAL, INC.
- Tendyne™ — ST. JUDE MEDICAL, INC.
- Tendyne™ — ST. JUDE MEDICAL, INC.
- Tendyne™ — ST. JUDE MEDICAL, INC.
- Tendyne™ — 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 66a735a2-a091-4722-abd4-3630fe73963d 37 fields · synced May 30, 2026