FDA product code PCW: Implantable Pulse Generator, Programmer And Battery Charger
PCW is the FDA product code for implantable pulse generator, programmer and battery charger. It is a Not classified device, reviewed by the Cardiovascular panel. Devices under PCW reach the market by Contact FDA; FDA lists no cleared 510(k)s for it.
Definition
intended for the treatment of moderate to severe heart failure.
Classification
| Field | Value |
|---|---|
| Device name | Implantable Pulse Generator, Programmer And Battery Charger |
| Device class | Not classified |
| Review panel | CV — Cardiovascular |
| Medical specialty | Unknown |
| Premarket route | Contact FDA |
| Implant | Yes |
Recalls for PCW devices
openFDA lists no recalls for product code PCW.
HCPCS codes with matching descriptors
Text match between the FDA device name and CMS descriptors, not an official crosswalk:
- C1820 — Generator, neurostimulator (implantable), with rechargeable battery and charging system
- C1767 — Generator, neurostimulator (implantable), non-rechargeable
Frequently asked questions
What is FDA product code PCW?
PCW is the FDA product code for implantable pulse generator, programmer and battery charger. It is a Not classified device, reviewed by the Cardiovascular panel.
What device class is PCW?
Not classified. Typical premarket route: Contact FDA.
Next steps
- Run an FDA pathway report with predicate devices for product code PCW
- Run a recall and safety report across every PCW manufacturer
- Watch product code PCW 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.