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Carpentier-Edwards Perimount Magna Mitral Ease Pericardial Bioprosthesis
FDA UDIClass III (US FDA UDI)
Identity
- Trade Name
- CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE PERICARDIAL BIOPROSTHESIS FDA UDI
- Generic Name
- Mitral open-surgery heart valve bioprosthesis FDA UDI
- Device Name
- CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE PERICARDIAL BIOPROSTHESIS FDA UDI
- Model / Reference
- 7300TFX FDA UDI
- Description
- CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE PERICARDIAL BIOPROSTHESIS FDA UDI
Identifiers
- Catalog Number
- 7300TFX33 FDA UDI
- Primary DI / UDI-DI
- 00690103186291 FDA UDI
- PMA Number
- P860057 FDA UDI
- FDA Product Code
- DYE FDA UDI
- GMDN Term
- Mitral 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
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
Yes
FDA UDI
MR Conditional FDA UDI
Category: Mitral open-surgery heart valve bioprosthesis
Carpentier-Edwards Perimount Magna Mitral Ease Pericardial Bioprosthesis by Edwards Lifesciences LLC — Class III — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as Mitral open-surgery heart valve bioprosthesis.
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- MOSAIC® — MEDTRONIC, INC. · Class III
- Biocor™ — ST. JUDE MEDICAL, INC. · Class III
- Epic™ — ST. JUDE MEDICAL, INC. · Class III
- HANCOCK® II — MEDTRONIC, INC. · Class III
- Biocor™ — ST. JUDE MEDICAL, INC. · Class III
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 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 76ce9112-b51f-4ad6-bf0f-8fe6fc2885d8 38 fields · synced Jun 8, 2026