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Alfapump System

by Sequana Medical NV

PMA P230044

Active United States

PMA

Valid until

No expiry

PMA approval is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

PMA P230044↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA PMA, synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPPR Approved NumberP230044 Date20 Dec 2024ApprovedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA PMA Active

Specification

PMA

Generic Name
alfapump System
PMA Number
FDA Product Code
SDQ
Device Class
Class III
Advisory Committee
Gastroenterology, Urology
FDA Decision
APPR Approved

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Alfapump System is a Class III implantable medical device classified under the product code SDQ, designed for single-patient use in adult patients with refractory or recurrent ascites due to liver cirrhosis. It functions as a peritoneal-to-bladder shunt, automatically and continuously removing excess peritoneal fluid from the abdominal cavity into the bladder for elimination via urination.

The device is supplied as a sterile, single-use implant intended for surgical placement under sterile conditions. It is regulated under an FDA Premarket Approval (PMA) with PMA number P230044 and is intended for use in clinical settings by trained medical professionals. Storage and handling must comply with sterile medical device protocols, and its dimensions or additional specifications are not detailed in the provided data.

Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the primary medical condition the alfapump System is designed to address in adult patients?

    The alfapump System is specifically designed for adult patients suffering from **refractory or recurrent ascites caused by liver cirrhosis**. It acts as a peritoneal-to-bladder shunt, automatically and continuously draining excess fluid from the abdominal cavity into the bladder for elimination through urination, providing relief for patients who do not respond well to conventional treatments.

  • Is the alfapump System intended for reuse, or is it meant to be used only once per patient?

    The alfapump System is **strictly single-use and single-patient only**, as explicitly stated in its intended use. It is implanted surgically and designed for one patient’s continuous use until removal, ensuring sterile conditions are maintained throughout its deployment.

  • How should the alfapump System be stored and handled to maintain its sterility?

    Since the alfapump System is supplied as a **sterile, single-use implant**, it must be stored and handled according to standard sterile medical device protocols. This includes keeping it in its original packaging until surgical implantation and ensuring no contamination occurs before or during the procedure.

  • What regulatory pathway was followed for the approval of the alfapump System in the U.S.?

    The alfapump System underwent **FDA Premarket Approval (PMA)** under PMA number **P230044**, which is the regulatory pathway for Class III devices. This approval was granted after a thorough review by the FDA, confirming its safety and effectiveness for the specified indication.