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CARPENTIER-EDWARDS Perimount Pericardial Aortic Prosthesis
FDA UDIClass III (US FDA UDI)
Identity
- Trade Name
- CARPENTIER-EDWARDS Perimount Pericardial Aortic Prosthesis FDA UDI
- Generic Name
- Aortic open-surgery heart valve bioprosthesis FDA UDI
- Device Name
- CARPENTIER-EDWARDS Perimount Pericardial Aortic Prosthesis FDA UDI
- Model / Reference
- 2700TFX FDA UDI
- Description
- CARPENTIER-EDWARDS Perimount Pericardial Aortic Prosthesis FDA UDI
Identifiers
- Catalog Number
- 2700TFX25MM FDA UDI
- Primary DI / UDI-DI
- 00690103194043 FDA UDI
- PMA Number
- P860057 FDA UDI
- FDA Product Code
- DYE FDA UDI
- GMDN Term
- Aortic open-surgery heart valve bioprosthesis FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Regulation Number
- 870.3925 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
No
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
CARPENTIER-EDWARDS Perimount Pericardial Aortic Prosthesis by Edwards Lifesciences LLC — Class III — FDA UDI — listed in FDA GUDID
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Also classified as Aortic open-surgery heart valve bioprosthesis.
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Cleared under the same submission
P860057 also covers:
- CARPENTIER-EDWARDS PERIMOUNT BIOPROSTHESIS AORTIC — Edwards Lifesciences LLC
- CARPENTIER-EDWARDS PERIMOUNT BIOPROSTHESIS AORTIC — Edwards Lifesciences LLC
- CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS - AORTIC — Edwards Lifesciences LLC
- CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS - AORTIC — Edwards Lifesciences LLC
- CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS - AORTIC — Edwards Lifesciences LLC
- CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS - AORTIC — Edwards Lifesciences LLC
- CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE PERICARDIAL BIOPROSTHESIS — Edwards Lifesciences LLC
- CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE PERICARDIAL BIOPROSTHESIS — Edwards Lifesciences LLC
- CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE PERICARDIAL BIOPROSTHESIS — Edwards Lifesciences LLC
- CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE PERICARDIAL BIOPROSTHESIS — Edwards Lifesciences LLC
- CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL PERICARDIAL BIOPROSTHESIS — Edwards Lifesciences LLC
- CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL PERICARDIAL BIOPROSTHESIS — 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 |
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Manufacturer
- Manufacturer
- Edwards Lifesciences LLC
Sources (1)
- FDA UDI c81841b4-8e45-4c01-a250-03ce961beea4 38 fields · synced Jun 8, 2026