PAL — Pulmonic Replacement Heart Valve Class f
FDA product code PAL covers "Pulmonic Replacement Heart Valve", a Class f medical device regulated under 21 CFR 870.3925. Submissions are reviewed by the Cardiovascular panel. Devices under this code are implants.
Classification Details
- Product Code
- PAL
- Device Class
- Class f
- Regulation Number
- 870.3925
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- Yes
Definition
For open surgical replacement of malfunctioning pulmonic heart valve.