FDA product code LWP: Implantable Pulse Generator, Pacemaker (Non-Crt)

LWP is the FDA product code for implantable pulse generator, pacemaker (non-crt). It is a Class III device, reviewed by the Cardiovascular panel. Devices under LWP reach the market by PMA; FDA lists no cleared 510(k)s for it. 36 PMA applications cite this product code. FDA has posted 113 recalls for LWP devices, 26 initiated in the last five years.

Definition

These devices treat bradycardia (slow heartbeats) with RA and/or RV pacing therapy as necessary.

Classification

Recalls for LWP devices

113 product recalls in 30 recall events; 26 initiated in the last five years and 53 still open. Most recent: 2026-03-19.

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
• C1820 — Generator, neurostimulator (implantable), with rechargeable battery and charging system

Frequently asked questions

What is FDA product code LWP?

LWP is the FDA product code for implantable pulse generator, pacemaker (non-crt). It is a Class III device, reviewed by the Cardiovascular panel.

What device class is LWP?

Class III. Typical premarket route: PMA.

Have LWP devices been recalled?

Yes: 113 product recalls across 30 recall events; the most recent began 2026-03-19.

Next steps

• Run an FDA pathway report with predicate devices for product code LWP
• Run a recall and safety report across every LWP manufacturer
• Watch product code LWP 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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