FDA product code PAL: Pulmonic Replacement Heart Valve
PAL is the FDA product code for pulmonic replacement heart valve. It is a HDE device, regulated under 21 CFR 870.3925 and reviewed by the Cardiovascular panel. Devices under PAL reach the market by Unclassified; FDA lists no cleared 510(k)s for it.
Definition
For open surgical replacement of malfunctioning pulmonic heart valve.
Classification
| Field | Value |
|---|---|
| Device name | Pulmonic Replacement Heart Valve |
| Device class | HDE |
| Regulation | 21 CFR 870.3925 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | Unclassified |
| Implant | Yes |
| Life-sustaining or supporting | Yes |
Recalls for PAL devices
openFDA lists no recalls for product code PAL.
Frequently asked questions
What is FDA product code PAL?
PAL is the FDA product code for pulmonic replacement heart valve. It is a HDE device, regulated under 21 CFR 870.3925 and reviewed by the Cardiovascular panel.
What device class is PAL?
HDE, regulation 21 CFR 870.3925. Typical premarket route: Unclassified.
Next steps
- Run an FDA pathway report with predicate devices for product code PAL
- Run a recall and safety report across every PAL manufacturer
- Watch product code PAL 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.