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The FDA Circulatory System Devices Panel has voted to retain Class III status for the temporary...

The FDA Circulatory System Devices Panel has voted to retain Class III status for the temporary ventricular support devices within the non-roller type cardiopulmonary bypass blood pumps category, which includes Abiomed's (ABMD) Impella 2.5. The retention of Class III status means that ABMD may now be required to file a pre-market approval application for the device, forcing the company to initiate additional clinical trials.
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