Laerdal Heartstart 3000 modifications do not require 510(k)s, FDA says.
This article was originally published in The Gray Sheet
Executive SummaryLAERDAL DOCUMENTS SUPPORTING HEARTSTART 3000 AED MODIFICATIONS were in FDA's possession prior to the agency's September 1994 issuance of a warning letter, Laerdal counsel Larry Pilot (McKenna & Cuneo) says in an Aug. 10 letter to FDA reiterating the firm's request that the warning letter be withdrawn. The company had petitioned FDA in October to withdraw the warning letter, and FDA responded on July 11.
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