FDA Product Code PZX: Left Atrial Appendage Clip, Implantable
Left atrial appendage occlusion reduces stroke risk in patients with atrial fibrillation who cannot take anticoagulants. FDA product code PZX covers implantable left atrial appendage clips.
These devices are applied epicardially to mechanically occlude the left atrial appendage from the outside of the heart, preventing thrombus formation in this common site of embolic stroke in AF patients. They represent an alternative to catheter-based endovascular LAA closure.
PZX devices are Class II medical devices, regulated under 21 CFR 878.4300 and reviewed by the FDA Cardiovascular panel.
Leading manufacturers include AtriCure, Inc..
FDA 510(k) Cleared Left Atrial Appendage Clip, Implantable Devices (Product Code PZX)
About Product Code PZX - Regulatory Context
510(k) Submission Activity
8 total 510(k) submissions under product code PZX since 2018, with 8 receiving FDA clearance (average review time: 88 days).
Submission volume has declined in recent years - 2 submissions in the last 24 months compared to 3 in the prior period.
FDA Review Time
Recent submissions under PZX have taken an average of 122 days to reach a decision - up from 77 days historically. Manufacturers should account for longer review timelines in current project planning.
PZX devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →