FDA product code MAD: Catheter, Percutaneous (Valvuloplasty)
MAD is the FDA product code for catheter, percutaneous (valvuloplasty). It is a Class III device, reviewed by the Cardiovascular panel. Devices under MAD reach the market by PMA; FDA lists no cleared 510(k)s for it. 1 PMA application cites this product code.
Classification
| Field | Value |
|---|---|
| Device name | Catheter, Percutaneous (Valvuloplasty) |
| Device class | Class III |
| Review panel | CV — Cardiovascular |
| Medical specialty | Unknown |
| Premarket route | PMA |
Recalls for MAD devices
openFDA lists no recalls for product code MAD.
Frequently asked questions
What is FDA product code MAD?
MAD is the FDA product code for catheter, percutaneous (valvuloplasty). It is a Class III device, reviewed by the Cardiovascular panel.
What device class is MAD?
Class III. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code MAD
- Run a recall and safety report across every MAD manufacturer
- Watch product code MAD 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.
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