FDA product code NPT: Aortic Valve, Prosthesis, Percutaneously Delivered

NPT is the FDA product code for aortic valve, prosthesis, percutaneously delivered. It is a Class III device, reviewed by the Cardiovascular panel. Devices under NPT reach the market by PMA; FDA lists no cleared 510(k)s for it. 8 PMA applications cite this product code. FDA has posted 33 recalls for NPT devices, 5 initiated in the last five years.

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.

Classification

Recalls for NPT devices

33 product recalls in 14 recall events; 5 initiated in the last five years and 8 still open. Most recent: 2024-10-17.

Frequently asked questions

What is FDA product code NPT?

NPT is the FDA product code for aortic valve, prosthesis, percutaneously delivered. It is a Class III device, reviewed by the Cardiovascular panel.

What device class is NPT?

Class III. Typical premarket route: PMA.

Have NPT devices been recalled?

Yes: 33 product recalls across 14 recall events; the most recent began 2024-10-17.

Next steps

• Run an FDA pathway report with predicate devices for product code NPT
• Run a recall and safety report across every NPT manufacturer
• Watch product code NPT for new clearances and recalls

Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.

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