Carpentier-Edwards Bioprosthesis Models 2625 and 6625
FDA PMAClass III (US FDA PMA)
Identity
- Trade Name
- CARPENTIER-EDWARDS BIOPROSTHESES MODELS 2625&6625 FDA PMA
- Generic Name
- replacement Heart-valve FDA PMA
Identifiers
- PMA Number
- P870056 FDA PMA
- FDA Product Code
- DYE FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Legislation / Framework
- 21 CFR Part 870.3925 FDA PMA
- Regulation Number
- 870.3925 FDA PMA
- Advisory Committee
- Cardiovascular FDA PMA
- FDA Decision
- APWD FDA PMA
The Carpentier-Edwards Bioprosthesis Models 2625 (aortic) and 6625 (mitral) are bioprosthetic heart valves designed for surgical replacement of dysfunctional native or previously implanted aortic or mitral valves. These devices are constructed from biological tissue to replicate the function of natural heart valves, ensuring proper blood flow through the heart’s chambers.
Intended for use in the operating room, these valves are implanted via open-heart surgery and are supplied sterile, single-use only. The models are classified under FDA Device Class III (PMA) and comply with regulation number 870.3925. Storage requires adherence to manufacturer guidelines to maintain sterility and integrity prior to surgical use.
Frequently asked questions
What are the key differences between the Carpentier-Edwards Bioprosthesis Models 2625 and 6625 in terms of their intended surgical use?
The Carpentier-Edwards Bioprosthesis Model 2625 is specifically designed for surgical replacement of a dysfunctional aortic valve, while the Model 6625 is intended for replacement of a mitral valve. Both are biological tissue valves meant to restore proper blood flow through their respective heart chambers during open-heart surgery.
Are the Carpentier-Edwards Bioprosthesis valves reusable, or are they meant for single-use only?
These valves are sterile and single-use only, as explicitly stated in the manufacturer’s instructions. They are intended for one-time surgical implantation and must not be reused after opening or exposure to the operating environment.
How should these valves be stored to ensure they remain sterile and intact before surgery?
Storage must follow the manufacturer’s guidelines to preserve sterility and structural integrity. Since they are single-use and sterile upon packaging, they should remain unopened and protected from contamination until immediately before use in the operating room.
What regulatory pathway was followed for FDA approval of these valves, and what does that mean for their clinical use?
The Carpentier-Edwards Bioprosthesis Models 2625 and 6625 were approved via the FDA’s Premarket Approval (PMA) process, classified under Device Class III. This pathway is reserved for high-risk medical devices, ensuring rigorous evaluation of safety and effectiveness before clinical use in patients with advanced aortic or mitral valvular disease.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P870056 | Class III | Active |
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Manufacturer
- Manufacturer
- Edwards Lifesciences LLC
- FDA Applicant
- Edwards Lifesciences, LLC
Sources (1)
- FDA PMA P870056 24 fields · synced Sep 18, 2026