FDA product code LWW: Pulse-Generator, Single Chamber, Single
LWW is the FDA product code for pulse-generator, single chamber, single. It is a Class III device, reviewed by the Cardiovascular panel. Devices under LWW 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, Single |
| Device class | Class III |
| Review panel | CV — Cardiovascular |
| Medical specialty | Unknown |
| Premarket route | PMA |
Recalls for LWW devices
openFDA lists no recalls for product code LWW.
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 LWW?
LWW is the FDA product code for pulse-generator, single chamber, single. It is a Class III device, reviewed by the Cardiovascular panel.
What device class is LWW?
Class III. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code LWW
- Run a recall and safety report across every LWW manufacturer
- Watch product code LWW 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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