In Brief: Possis Medical
This article was originally published in The Gray Sheet
Executive Summary
Possis Medical: Plans to respond within 45 days to "a series of questions" raised by FDA about its pending 510(k) application for the AngioJet rapid thrombectomy system for peripheral applications, the firm states in a June 20 release. The application was filed earlier this year ("The Gray Sheet" March 18, In Brief). The Minneapolis firm "believes its answers will support a favorable decision by the FDA"...