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FDA PMA

alfapump System

PMA Number: P230044 · 2026-05-05

ApplicantSequana Medical NV
Decision Date2026-05-05
PMA NumberP230044
Product CodeSDQ
Device ClassClass 3
Medical SpecialtyU
Advisory CommitteeGU

Device Summary

alfapump System is a medical device manufactured by Sequana Medical NV. It received FDA Premarket Approval (PMA) on 2026-05-05 under PMA number P230044. The device is classified under FDA product code SDQ. It was reviewed by the GU advisory panel. This device is classified as Class III by the FDA. Class III devices subject to the most stringent regulatory controls. These devices generally require premarket approval (PMA) because they support or sustain human life, are of substantial importance in preventing impairment of human health, or present a potential unreasonable risk of illness or injury. PMA is the most stringent type of device marketing application required by the FDA. The device falls under the medical specialty of U. Unlike 510(k) clearance, which demonstrates substantial equivalence to a predicate device, PMA requires the manufacturer to submit clinical trial data demonstrating the safety and effectiveness of the device. PMA is generally required for Class III devices that support or sustain human life, are of substantial importance in preventing impairment of human health, or present a potential unreasonable risk of illness or injury.

Frequently Asked Questions

What is alfapump System?

alfapump System is a medical device that received FDA Premarket Approval (PMA) on 2026-05-05. It is manufactured by Sequana Medical NV. The PMA number is P230044.

When did alfapump System receive FDA PMA approval?

alfapump System received FDA PMA approval on 2026-05-05, under approval number P230044.

What company makes alfapump System?

alfapump System is manufactured by Sequana Medical NV.

What is the difference between PMA and 510(k)?

PMA (Premarket Approval) is the FDA process for evaluating Class III medical devices. Unlike 510(k) clearance, which demonstrates substantial equivalence to a predicate device, PMA requires the manufacturer to provide clinical data proving safety and effectiveness. PMA is the most stringent type of device marketing application required by the FDA.

What is the FDA product code for alfapump System?

The FDA product code for alfapump System is SDQ.

What FDA device class is alfapump System?

alfapump System is classified as Class III by the FDA.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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