Identity
- Trade Name
- INSPIRIS RESILIA AORTIC VALVE FDA UDI
- Generic Name
- Aortic open-surgery heart valve bioprosthesis FDA UDI
- Device Name
- INSPIRIS RESILIA AORTIC VALVE FDA UDI
- Model / Reference
- 11500A FDA UDI
- Description
- INSPIRIS RESILIA AORTIC VALVE FDA UDI
Identifiers
- Catalog Number
- 11500A29 FDA UDI
- Primary DI / UDI-DI
- 00690103195019 FDA UDI
- PMA Number
- P150048 FDA UDI
- FDA Product Code
- LWR FDA UDI
- GMDN Term
- Aortic open-surgery 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: Aortic open-surgery heart valve bioprosthesis
Inspiris Resilia Aortic Valve by Edwards Lifesciences LLC — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Aortic open-surgery heart valve bioprosthesis.
- MOSAIC ULTRA® — MEDTRONIC, INC. · Class III
- MOSAIC ULTRA® — MEDTRONIC, INC. · Class III
- Trifecta™ — ST. JUDE MEDICAL, INC. · Class III
- MOSAIC® — MEDTRONIC, INC. · Class III
- Biocor™ — ST. JUDE MEDICAL, INC. · Class III
- MOSAIC ULTRA® — MEDTRONIC, INC. · Class III
- MOSAIC ULTRA® — MEDTRONIC, INC. · Class III
- HANCOCK II ULTRA® — MEDTRONIC, INC. · Class III
Cleared under the same submission
P150048 also covers:
- INSPIRIS RESILIA AORTIC VALVE — Edwards Lifesciences LLC
- INSPIRIS RESILIA AORTIC VALVE — Edwards Lifesciences LLC
- INSPIRIS RESILIA AORTIC VALVE — Edwards Lifesciences LLC
- INSPIRIS RESILIA AORTIC VALVE — Edwards Lifesciences LLC
- INSPIRIS RESILIA AORTIC VALVE — Edwards Lifesciences LLC
- KONECT RESILIA — Edwards Lifesciences LLC
- KONECT RESILIA — Edwards Lifesciences LLC
- KONECT RESILIA — Edwards Lifesciences LLC
- KONECT RESILIA — Edwards Lifesciences LLC
- KONECT RESILIA — Edwards Lifesciences LLC
- KONECT RESILIA — Edwards Lifesciences LLC
- MITRIS RESILIA Mitral Valve — Edwards Lifesciences LLC
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Edwards Lifesciences LLC
Sources (1)
- FDA UDI f90b3192-14d3-49bb-95be-0746ac3a1481 38 fields · synced Jun 8, 2026