FDA product code SDL: Transvenous Temporary Phrenic Nerve Stimulator
SDL is the FDA product code for transvenous temporary phrenic nerve stimulator. It is a Class III device, reviewed by the Anesthesiology panel. Devices under SDL reach the market by PMA; FDA lists no cleared 510(k)s for it. 1 PMA application cites this product code.
Definition
The device is intended to be implanted transvenously to stimulate the phrenic nerves to improve weaning from a mechanical ventilator. The device is temporary (<30 days) and is for use only in patients 18 years of age or older.
Classification
| Field | Value |
|---|---|
| Device name | Transvenous Temporary Phrenic Nerve Stimulator |
| Device class | Class III |
| Review panel | AN — Anesthesiology |
| Medical specialty | Unknown |
| Premarket route | PMA |
Recalls for SDL devices
openFDA lists no recalls for product code SDL.
Frequently asked questions
What is FDA product code SDL?
SDL is the FDA product code for transvenous temporary phrenic nerve stimulator. It is a Class III device, reviewed by the Anesthesiology panel.
What device class is SDL?
Class III. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code SDL
- Run a recall and safety report across every SDL manufacturer
- Watch product code SDL 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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