Aortic Valve, Prosthesis, Percutaneously Delivered
The percutaneously delivered aortic valve prosthesis is a cardiovascular implant designed to replace a patient's diseased aortic heart valve via a catheter-based approach through the vasculature, eliminating the need for open-chest surgery or cardiotomy. It is classified as FDA Class 3, the highest risk category, requiring Premarket Approval (PMA) given the life-critical nature of heart valve replacement. Product code NPT carries both implant and life-sustaining flags and is reviewed by the Cardiovascular panel.
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Basic Information
- Product Code
- NPT
- Device Class
- FDA class 3
- Medical Specialty
- Unknown
- Review Panel
- CV
- Submission Type
- 2
Device Characteristics
Definition
To replace a patient's aortic heart valve. They are different from the classified device (heart valves) in that they are placed percutaneously and do not require open chest surgery or a cardiotomy for placement.
FEI Numbers
This FDA classification entry is associated with 23 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 23 registration numbers. Click on an entry to view related FDA registrations.