December 17, 2012 — Abiomed Inc. announced the U.S. Food and Drug Administration's (FDA) Circulatory System Devices Panel voted to retain Class III status for the temporary ventricular support devices within the non-roller type cardiopulmonary bypass blood pumps category, which includes Impella. The 515i Reclassification Panel's confirmation of this category of device as Class III devices is consistent with both the current Class III classification for these device types and as recommended in the FDA's briefing documents, released Dec. 3, 2012.
"We would like to thank the 515i panel and FDA for their time and consideration, as well as Jeffrey Popma of Beth Israel Deaconess Medical Center and William O'Neill of Henry Ford Hospital, who highlighted the compelling body of clinical evidence supporting Impella, including the PROTECT II dataset," said Michael R. Minogue, president, chairman and CEO of Abiomed. "We look forward to collaborating with the FDA on next steps and agree with the 515i panel's feedback that our existing data, combined with our U.S. registry, position us to work with the FDA to submit a PMA [premarket approval] application. We welcome the opportunity for a PMA to strengthen our existing marketing clearances and expand the indications for Impella patients."
The FDA's 515i program is designed to review all previously 510(k)-cleared Class III devices and determine the appropriate controls to ensure safety and effectiveness for the intended use of these product categories. The classification of Impella as a Class III device requires PMA controls (versus prior 510(k) Class III special controls) to ensure safety and effectiveness in the intended use. As per the 515i Reclassification Process and confirmed by the FDA panel, products will remain on the market for a sufficient period to allow for manufacturers to submit and the FDA to review premarket approval applications.
As per the statues of the 515i program, there is no change to the current 510(k) clearance for Impella throughout the remaining steps of the reclassification process for non-roller type cardiopulmonary bypass pumps. Following the panel recommendation, the next steps in the 515i process include FDA issuance of a proposed final order, followed by a period of public comment, FDA issuance of a final order, and then submission of PMA applications by manufacturers with devices in the category. Throughout this series of reclassification steps, Abiomed will continue to market the Impella family of heart pumps and work with the FDA to submit the necessary clinical data under the PMA application process.
For more information: www.abiomed.com
October 31, 2023 
