PAP — Aortic Heart Valve, More Than Minimally Manipulated Allograft Class f
FDA product code PAP covers "Aortic Heart Valve, More Than Minimally Manipulated Allograft", a Class f medical device. Submissions are reviewed by the Unknown panel. Devices under this code are implants.
Classification Details
- Product Code
- PAP
- Device Class
- Class f
- Regulation Number
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Unknown
- Implant
- Yes
Definition
Intended for use in the replacement of diseased, damaged, malformed, or malfunctioning native or prosthetic aortic valves in pediatric patients.