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U.S. Department of Health and Human Services

Product Classification
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Device alfapump system
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.
Physical State Implantable gear pump with catheters and system components, which include Smart Charger and Docking Station, and laptop/notebook to charge and program the implantable pump and wirelessly receive pump data
Technical Method Uses a implantable, and inductively charged gear pump, with a Peritoneal Catheter and Bladder catheter to remove excess peritoneal fluid from the peritoneal cavity into the bladder, where the fluid can be eliminated through normal urination.
Target Area abdomen, peritoneal cavity, and bladder
Review Panel Gastroenterology/Urology
Product CodeSDQ
Premarket Review Renal, Gastrointestinal, Obesity and Transplant Devices (DHT3A)
Renal, Gastrointestinal, Obesity and Transplant Devices (DHT3A)
Submission Type PMA
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Ineligible
Implanted Device? Yes
Life-Sustain/Support Device? Yes
Third Party Review Not Third Party Eligible
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