Data / Medical devices / Implantable Pulse Generator, Pacemaker (Non-Crt)

Implantable Pulse Generator, Pacemaker (Non-Crt) (LWP): 24 FDA-registered makers in 10 countries

24 establishments in 10 countries are registered with the FDA to make Implantable Pulse Generator, Pacemaker (Non-Crt) (product code LWP, Class 3). 13 of them have a 510(k) clearance or PMA approval on file and 3 have a recall event. The FDA has issued 0 510(k) clearances under this code, and lists 30 recall events (4 Class I). FDA data exported November 2, 2026.

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Product code

LWP

Device class

3

Medical specialty

Unknown

Implant

Yes

Life sustaining or supporting

Yes

Makers by country

Makers of Implantable Pulse Generator, Pacemaker (Non-Crt)

Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.

Updated November 2, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.