PAP
- Product code
- PAP
- Device name
- Aortic Heart Valve, More Than Minimally Manipulated Allograft
- Device class
- Class F
- Medical specialty
- Unknown
- Marketing pathway
- HDE - Humanitarian Device Exemption
- Flag
- Implant
- Flag
- Life-sustaining / life-supporting
FDA classification definition
Intended for use in the replacement of diseased, damaged, malformed, or malfunctioning native or prosthetic aortic valves in pediatric patients.
Official FDA classification page: PAP
Classification and pathway per current FDA publications. Data from openFDA (CC0).