News | News By Subject | News by Disease News By Date | Search News
Get Our FREE
Industry eNewsletter
email:    
   

FDA Warns Abiomed (ABMD) on Unauthorized Heart Pump Marketing


6/29/2011 9:31:57 AM

Shares in Abiomed Inc. (Nasdaq: ABMD) fell Tuesday after the company received a letter from the Food and Drug Administration accusing the company of marketing one of its Impella heart pumps without marketing clearance. Abiomed, based in Danvers, made several “objectionable” claims about the potential uses for the Impella Recover LP 2.5 device, in an advertisement last September in Cath Lab Digest, according to the FDA. “These claims represent a major modification to both the intended use and the indications for use of the device,” the FDA said in the warning letter to the company, dated June 10.

Read at Mass High Tech
Read at Investors
Read at MassDevice


comments powered by Disqus
   

ADD TO DEL.ICIO.US    ADD TO DIGG    ADD TO FURL    ADD TO STUMBLEUPON    ADD TO TECHNORATI FAVORITES