FDA product code LOT: Pulse-Generator, Program Module
LOT is the FDA product code for pulse-generator, program module. It is a Class III device, reviewed by the Cardiovascular panel. Devices under LOT 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 | Pulse-Generator, Program Module |
| Device class | Class III |
| Review panel | CV — Cardiovascular |
| Medical specialty | Unknown |
| Premarket route | PMA |
Recalls for LOT devices
openFDA lists no recalls for product code LOT.
HCPCS codes with matching descriptors
Text match between the FDA device name and CMS descriptors, not an official crosswalk:
- C8009 — Removal of hypoglossal nerve neurostimulator array and pulse generator
Frequently asked questions
What is FDA product code LOT?
LOT is the FDA product code for pulse-generator, program module. It is a Class III device, reviewed by the Cardiovascular panel.
What device class is LOT?
Class III. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code LOT
- Run a recall and safety report across every LOT manufacturer
- Watch product code LOT 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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