NPVHumanitarian device exemption

Pulmonary Valve Prosthesis Percutaneously Delivered

Unknown

NPV is the FDA product code for Pulmonary Valve Prosthesis Percutaneously Delivered. FDA's definition for this code reads: "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". As of 2026-09-10, FDA records hold no 510(k) clearances under this code and 2 recalls.

Classification record

Product code: NPV
Device name: Pulmonary Valve Prosthesis Percutaneously Delivered
FDA 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.
Device class: Humanitarian device exemption
Review panel: Unknown
Submission type: PMA
Implant: Yes
Life sustaining or supporting: Yes
GMP exempt: No
Third party review eligible: No
Ingested clearances: 0
Ingested recalls: 2

Companies listing this code with FDA

Companies whose registered establishments list this code

Recent clearances

Product code NPV

FDA records hold no clearances under product code NPV.

Recent recalls

Product code NPV

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device classification database, ingested from openFDA. The definition, regulation number, device class and review panel are FDA’s own fields, reproduced without editing.

MDM adds the counts: clearances by decision year, the applicants holding the most clearances under this code, recalls that name it, and the registered establishments that list it. Every count is computed from ingested records only.

Data as of 2026-10-05, the FDA export date for this dataset. Page last changed 2026-09-05. View this product code on fda.gov (opens on fda.gov)