SDQ

Alfapump System

Product code: SDQ
Device name: Alfapump System
Device class: Class 3
Medical specialty: Unknown
Marketing pathway: PMA
Flag: Implant
Flag: Life-sustaining / life-supporting

FDA classification definition

The alfapump System is intended for single patient use only in adult patients with refractory or recurrent ascites due to liver cirrhosis. It is indicated for the removal of excess peritoneal fluid from the peritoneal cavity into the bladder, where it can be eliminated through normal urination.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

Official FDA classification page: SDQ

Classification and pathway per current FDA publications. Data from openFDA (CC0).