FDA product code LWS: Implantable Cardioverter Defibrillator (Non-Crt)

LWS is the FDA product code for implantable cardioverter defibrillator (non-crt). It is a Class III device, reviewed by the Cardiovascular panel. Devices under LWS reach the market by PMA; FDA lists no cleared 510(k)s for it. 27 PMA applications cite this product code. FDA has posted 219 recalls for LWS devices, 93 initiated in the last five years.

Definition

These devices treat tachycardia (fast heartbeats) with RV defibrillation therapy as necessary.

Classification

Recalls for LWS devices

219 product recalls in 73 recall events; 93 initiated in the last five years and 98 still open. Most recent: 2025-10-29.

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 LWS?

LWS is the FDA product code for implantable cardioverter defibrillator (non-crt). It is a Class III device, reviewed by the Cardiovascular panel.

What device class is LWS?

Class III. Typical premarket route: PMA.

Have LWS devices been recalled?

Yes: 219 product recalls across 73 recall events; the most recent began 2025-10-29.

Next steps

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