FDA product code LWO: Pulse-Generator, Single Chamber, Sensor Driven, Implantable
LWO is the FDA product code for pulse-generator, single chamber, sensor driven, implantable. It is a Class III device, reviewed by the Cardiovascular panel. Devices under LWO reach the market by PMA; FDA lists no cleared 510(k)s for it. 3 PMA applications cite this product code.
Classification
| Field | Value |
|---|---|
| Device name | Pulse-Generator, Single Chamber, Sensor Driven, Implantable |
| Device class | Class III |
| Review panel | CV — Cardiovascular |
| Medical specialty | Unknown |
| Premarket route | PMA |
| Implant | Yes |
Recalls for LWO devices
openFDA lists no recalls for product code LWO.
HCPCS codes with matching descriptors
Text match between the FDA device name and CMS descriptors, not an official crosswalk:
- C1767 — Generator, neurostimulator (implantable), non-rechargeable
Frequently asked questions
What is FDA product code LWO?
LWO is the FDA product code for pulse-generator, single chamber, sensor driven, implantable. It is a Class III device, reviewed by the Cardiovascular panel.
What device class is LWO?
Class III. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code LWO
- Run a recall and safety report across every LWO manufacturer
- Watch product code LWO 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.
All Cardiovascular product codes · FDA product code lookup · 510(k) database search · 510(k) review times