Identity
- Trade Name
- FREEDOM SOLO STENTLESS HEART VALVE FDA PMA
- Generic Name
- heart-valve, non-allograft tissue FDA PMA
Identifiers
- PMA Number
- P130011 FDA PMA
- FDA Product Code
- LWR FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Cardiovascular FDA PMA
- FDA Decision
- APWD FDA PMA
The Solo Smart Heart Valve is a stentless, non-allograft tissue heart valve designed for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic valves. It is indicated for use in patients requiring aortic valve replacement due to valvular disease.
This device is supplied sterile and intended for single-use implantation in a hospital setting by qualified cardiovascular surgeons. It is regulated as a Class III medical device under FDA PMA approval (P130011) and is not indicated for MRI safety assessment in the provided data.
Frequently asked questions
What type of valve is the Solo Smart Heart Valve?
The Solo Smart Heart Valve is a stentless, non-allograft tissue heart valve, meaning it lacks a synthetic stent and is made from biological tissue not derived from human donors.
What is the Solo Smart Heart Valve used for?
It is used for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic valves in patients requiring aortic valve replacement.
Is the Solo Smart Heart Valve approved for use in the United States?
Yes, the Solo Smart Heart Valve has received FDA Premarket Approval (PMA) under application number P130011, which was granted on June 24, 2014.
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 | P130011 | Class III | Active |
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Manufacturer
- Manufacturer
- Corcym Canada Corp
Sources (1)
- FDA PMA P130011 24 fields · synced Sep 18, 2026