Edwards Prima Plus Stentless Bioprosthesis Model 2500P
FDA PMAClass III (US FDA PMA)
Identity
- Trade Name
- EDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS MODEL 2500P FDA PMA
- Generic Name
- replacement Heart-valve FDA PMA
Identifiers
- PMA Number
- P000007 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 Edwards Prima Plus Stentless Bioprosthesis Model 2500P is a replacement heart-valve designed for aortic valve replacement. It is a stentless bioprosthetic valve intended to replicate the natural anatomy and hemodynamics of the native aortic valve, providing durable function for patients requiring surgical intervention.
This device is supplied in sizes 21, 23, 25, and 27 mm and is intended for use in the subcoronary implantation technique. It is classified as a Class III medical device under FDA regulations and has received FDA_PMA authorization. The device is non-sterile upon receipt and must be sterilized prior to use, adhering to standard surgical protocols for cardiac bioprostheses.
Frequently asked questions
What sizes are available for the Edwards Prima Plus Stentless Bioprosthesis Model 2500P, and how does this affect its use in surgery?
The Edwards Prima Plus Stentless Bioprosthesis Model 2500P is available in sizes 21 mm, 23 mm, 25 mm, and 27 mm. These sizes correspond to the anatomical dimensions of the patient’s aortic valve annulus, allowing surgeons to select the appropriate valve to ensure proper fit and function. The subcoronary implantation technique is specifically designed for this device, which requires precise sizing to replicate the native aortic valve’s hemodynamics and anatomy.
Is the Edwards Prima Plus Stentless Bioprosthesis Model 2500P intended for reuse, or is it single-use?
The Edwards Prima Plus Stentless Bioprosthesis Model 2500P is **not** intended for reuse. Like most cardiac bioprostheses, it is designed for single-use in surgical procedures. The device must be sterilized prior to use, following standard surgical protocols for cardiac bioprostheses, but it is not meant to be reprocessed or reused after implantation.
How should the Edwards Prima Plus Stentless Bioprosthesis Model 2500P be stored before use, given it is non-sterile upon receipt?
Since the Edwards Prima Plus Stentless Bioprosthesis Model 2500P is **non-sterile** upon receipt, it must be stored in its original packaging in a clean, dry environment away from direct sunlight or extreme temperatures. Sterilization must be performed prior to use, adhering to validated protocols for cardiac bioprostheses to ensure safety and efficacy before surgical implantation.
What regulatory pathway was followed for the Edwards Prima Plus Stentless Bioprosthesis Model 2500P, and what does this mean for its use?
The Edwards Prima Plus Stentless Bioprosthesis Model 2500P followed the **FDA Pre-Market Approval (PMA)** pathway, which is required for Class III medical devices like replacement heart valves. This means the device underwent rigorous clinical evaluation to demonstrate safety and effectiveness for its intended use—replacing the native or prosthetic aortic valve via the subcoronary implantation technique—before receiving FDA authorization (PMA #P000007).
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. Sources consulted: Edwards Lifesciences – the leading global structural heart innovation ..., Edwards Lifesciences – the leading global structural heart innovation ..., Edwards Lifesciences – Wikipedia, Edwards Lifesciences - Wikipedia, Edwards Lifesciences - Herzmedizin.de
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P000007 | Class III | Active |
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Manufacturer
- Manufacturer
- Edwards Lifesciences LLC
- FDA Applicant
- Edwards Lifesciences, LLC
Sources (1)
- FDA PMA P000007 24 fields · synced Sep 18, 2026