Panel votes to lower risk classification for certain balloon pumps

12/7/2012 | Clinica (subscription required)

An FDA panel has voted to recommend the reclassification of intra-aortic balloon pumps used in acute coronary syndrome, heart failure complications, and cardiac and non-cardiac procedures from Class III to Class II medical devices. The devices will now be subjected to the 510(k) clearance process instead of the tougher premarket approval program.

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