Identity
- Trade Name
- Ensemble™ ll FDA UDI
- Generic Name
- Pulmonary transcatheter heart valve bioprosthesis FDA UDI
- Device Name
- DELIV SYS ENS1018 ENSEMBLE II US FDA UDI
- Model / Reference
- ENS1018 FDA UDI
- Description
- DELIV SYS ENS1018 ENSEMBLE II US FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00643169713888 FDA UDI
- PMA Number
- P140017 FDA UDI
- FDA Product Code
- NPV FDA UDI
- GMDN Term
- Pulmonary transcatheter heart valve bioprosthesis FDA UDI
Classification
- Device Class
- Unclassified 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Pulmonary transcatheter heart valve bioprosthesis
Ensemble™ ll by Medtronic, Inc. — Class Unclassified — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Pulmonary transcatheter heart valve bioprosthesis.
- EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE (THV) — Edwards Lifesciences LLC · Class III
- EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE (THV) — Edwards Lifesciences LLC · Class III
- EDWARDS COMMANDER DELIVERY SYSTEM — Edwards Lifesciences LLC · Class III
- EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE (THV) — Edwards Lifesciences LLC · Class III
- EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE (THV) — Edwards Lifesciences LLC · Class III
- EDWARDS SAPIEN 3 PULMONIC DELIVERY SYSTEM (29MM) — Edwards Lifesciences LLC · Unclassified
- EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE (THV) — Edwards Lifesciences LLC · Class III
- EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE (THV) — Edwards Lifesciences LLC · Class III
Cleared under the same submission
P140017 also covers:
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 Unclassified | Pending data |
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Manufacturer
- Manufacturer
- Medtronic, Inc.
Sources (1)
- FDA UDI b8532f46-7f5f-418e-9a16-6264c60d907d 37 fields · synced May 30, 2026