FDA Product Code LDF: Electrode, Pacemaker, Temporary
Temporary pacemakers provide immediate cardiac pacing during hemodynamic emergencies. FDA product code LDF covers temporary pacemaker electrodes used for short-term cardiac stimulation.
These catheters are placed transvenously or epicardially to deliver electrical impulses to the myocardium for temporary rate support during symptomatic bradycardia, post-cardiac surgery, and as a bridge to permanent pacemaker implantation.
LDF devices are Class II medical devices, regulated under 21 CFR 870.3680 and reviewed by the FDA Cardiovascular panel.
Leading manufacturers include C.R. Bard, Inc., Medtronic, Inc. and Bioptimal International Pte. , Ltd..
FDA 510(k) Cleared Electrode, Pacemaker, Temporary Devices (Product Code LDF)
About Product Code LDF - Regulatory Context
510(k) Submission Activity
128 total 510(k) submissions under product code LDF since 1978, with 128 receiving FDA clearance (average review time: 132 days).
Submission volume has increased in recent years - 5 submissions in the last 24 months compared to 1 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under LDF have taken an average of 192 days to reach a decision - up from 129 days historically. Manufacturers should account for longer review timelines in current project planning.
LDF devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →