Identity
- Trade Name
- Tendyne™ FDA UDI
- Generic Name
- Self-expandable heart valve bioprosthesis collapsing tool, single-use FDA UDI
- Device Name
- Loading System FDA UDI
- Model / Reference
- TENDV-LS FDA UDI
- Description
- Loading System FDA UDI
Identifiers
- Catalog Number
- TENDV-LS FDA UDI
- Primary DI / UDI-DI
- 05415067032706 FDA UDI
- PMA Number
- P240042 FDA UDI
- FDA Product Code
- NPU FDA UDI
- GMDN Term
- Self-expandable heart valve bioprosthesis collapsing tool, single-use 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
No
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Self-expandable heart valve bioprosthesis collapsing tool, single-use
Tendyne™ by St. Jude Medical, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Self-expandable heart valve bioprosthesis collapsing tool, single-use.
- Perceval S Single Use MICS Accessory Kit — CORCYM SRL
- PERCEVAL S — Corcym Inc. · Class III
- Perceval S Single Use MICS Accessory Kit — CORCYM SRL
- Perceval S Single Use Accessory Kit — CORCYM SRL
- Perceval S Single Use Accessory Kit — CORCYM SRL
- Perceval S Single Use MICS Accessory Kit — CORCYM SRL
- Perceval S Single Use Accessory Kit — CORCYM SRL
- Perceval S Single Use Accessory Kit — CORCYM SRL
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 0d2305c7-1f1a-473c-b13f-2e37ff145b29 37 fields · synced Jun 8, 2026