SDQ · Class III — High Risk (PMA approval required, life-sustaining) · Unknown
Classification
FDA Product Code
SDQ
Device class
Class III — High Risk (PMA approval required, life-sustaining)
Regulation
—
Review panel
GU
Medical specialty
Unknown
Submission type
2
GMP exempt
N
Life sustaining
Y
Implant
Y
Third-party review
N
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.