FDA Approves Cardiovascular Systems’ Replacement Saline Infusion Pump

Tuesday, July 7, 2020

Cardiovascular Systems, Inc. (CSI) (Nasdaq: CSII) today announced that the U.S. Food and Drug Administration (FDA) has approved its premarket approval application (PMA) supplement for a redesigned saline pump used as part of the company’s Diamondback 360® Orbital Atherectomy Systems (OAS). The 70057-03 Saline Infusion Pump will replace CSI’s 7-10014 Saline Infusion Pump, which the company voluntarily recalled on April 17, 2017.

The company anticipates replacing all recalled units by no later than August 31, 2017.

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