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Quotes & Info
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| ABMD > SEC Filings for ABMD > Form 8-K on 7-Dec-2012 | All Recent SEC Filings |
7-Dec-2012
Other Events, Financial Statements and Exhibits
On December 6, 2012, we issued a press release announcing that 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, under which our Impella products are categorized. A copy of the press release is attached as exhibit 99.1 to this current report on Form 8-K and incorporated herein by reference.
Dr. David Weber our Chief Operating Officer, Dr. Jeffrey Popma of Beth Israel Deaconess Medical Center in Boston and Dr. William O'Neill of Henry Ford Hospital led a presentation to the FDA's Circulatory System Devices Panel related to the classification of our Impella devices on December 6, 2012. A copy of the slides used in the presentation is attached as exhibit 99.2 to this current report on Form 8-K and incorporated herein by reference. Also attached as exhibit 99.3 to this current report on Form 8-K and incorporated herein by reference is a copy of a summary we provided to the FDA on December 6, 2012 listing clinical and scientific publications on the Impella 2.5, Impella 5.0 and Impella LD.
(d) Exhibits
Number Description
99.1 Press release dated December 6, 2012.
99.2 Abiomed Presentation to FDA 515i Panel Classification Determination
for Non-roller Type CPB Pumps dated December 6, 2012.
99.3 Impella Clinical Literature Summary.
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