Pulmonary Valve Prosthesis Percutaneously Delivered
The percutaneously delivered pulmonary valve prosthesis is a cardiovascular implant designed to replace a patient's diseased pulmonary heart valve via a catheter-based approach without the need for open-chest surgery or cardiotomy. Its device class is listed as "f" (unclassified/pending classification), indicating the regulatory classification was not yet determined at the time of record creation. Product code NPV carries both implant and life-sustaining flags, is reviewed by the Cardiovascular panel, and requires a PMA-type submission.
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Basic Information
- Product Code
- NPV
- Medical Specialty
- Unknown
- Review Panel
- CV
- Submission Type
- 2
Device Characteristics
Definition
These devices are intended to replace a patient's pulmonary 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 13 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 13 registration numbers. Click on an entry to view related FDA registrations.