FDA product code PAP: Aortic Heart Valve, More Than Minimally Manipulated Allograft
PAP is the FDA product code for aortic heart valve, more than minimally manipulated allograft. It is a HDE device, reviewed by the Cardiovascular panel. Devices under PAP reach the market by Unclassified; FDA lists no cleared 510(k)s for it.
Definition
Intended for use in the replacement of diseased, damaged, malformed, or malfunctioning native or prosthetic aortic valves in pediatric patients.
Classification
| Field | Value |
|---|---|
| Device name | Aortic Heart Valve, More Than Minimally Manipulated Allograft |
| Device class | HDE |
| Review panel | CV — Cardiovascular |
| Medical specialty | Unknown |
| Premarket route | Unclassified |
| Implant | Yes |
| Life-sustaining or supporting | Yes |
Recalls for PAP devices
openFDA lists no recalls for product code PAP.
Frequently asked questions
What is FDA product code PAP?
PAP is the FDA product code for aortic heart valve, more than minimally manipulated allograft. It is a HDE device, reviewed by the Cardiovascular panel.
What device class is PAP?
HDE. Typical premarket route: Unclassified.
Next steps
- Run an FDA pathway report with predicate devices for product code PAP
- Run a recall and safety report across every PAP manufacturer
- Watch product code PAP 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.