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FDA panel recommends deflating heart balloon pumps risk category; but Abiomed's Impella likely faces stricter regs

This article was originally published in Clinica

Executive Summary

As expected, a US FDA advisory panel has unanimously recommended that intra-aortic balloon pumps should be reclassified as Class II devices for their core indications, meaning they will be subject to the less stringent 510(k) pathway. Until now, IABPs have been pre-amendment Class III devices cleared through the 510(k) pathway – if the classification had remained at Class III, they would have had to go through the stricter premarket approval (PMA) process.

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