Percutaneously Delivered Prostheses And Tricuspid Valves
The percutaneously delivered tricuspid valve prosthesis is a cardiovascular implant intended to replace a patient's diseased tricuspid heart valve using a minimally invasive percutaneous catheter-based approach, avoiding open-chest surgery or cardiotomy. It is classified as FDA Class 3, the highest risk category, requiring Premarket Approval (PMA) due to the life-critical function of heart valve replacement. Product code NPW carries both implant and life-sustaining flags and is reviewed by the Cardiovascular panel.
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Basic Information
- Product Code
- NPW
- Device Class
- FDA class 3
- Medical Specialty
- Unknown
- Review Panel
- CV
- Submission Type
- 2
Device Characteristics
Definition
These devices are intended to replace a patient's tricuspid heart valve. They are different from the classified device (heart valves) in that they are placed percutaniously and do not require open chest surgery or a cardiotomy for placement.
FEI Numbers
This FDA classification entry is associated with 5 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 5 registration numbers. Click on an entry to view related FDA registrations.