DeviceClearance

Product code PZX— General, Plastic Surgery

ATLAAS (Atraumatic Left Atrial Appendage System) (AD)

Classification name
Left Atrial Appendage Clip, Implantable
Device class
Class 2
Regulation
21 CFR 878.4300
Advisory panel
General, Plastic Surgery
Total cleared
10
First cleared
Most recent

FDA classification definition

“Intended to occlude the left atrial appendage.”

— U.S. Food and Drug Administration, device classification record for product code PZX under 21 CFR 878.4300, via openFDA

Market context for product code PZX

FDA has cleared 10 devices under product code PZX between 2018 and 2026, filed by 5 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code PZX

Adverse events under product code PZX

product code PZX
Death
6
Total
6

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recent clearances under product code PZX

Data sourced from openFDA. This site is unofficial and independent of the FDA.