FDA Approvals - Kensey Nash Receives FDA 510(k) Clearance For TriActiv FX(R) Embolic
Kensey Nash Receives FDA 510(k) Clearance For TriActiv FX(R) Embolic Protection System (Medical News Today)
Kensey Nash Corporation(Nasdaq: KNSY) today announced that it has received 510(k) clearance forits next generation TriActiv FX(R) Embolic Protection System from the U.S.Food and Drug Administration (FDA). The product is expected to be launchedshortly. [click link for full article]
Cyberonics Receives FDA Approval for Harmonized/Modularized VNS Therapy System Labeling Format (SYS-CON Media)
Cyberonics, Inc. today announced that it received FDA approval for a harmonized/modularized VNS Therapy(TM) System labeling format and FDA approval to market the VNS Therapy Model 250 Version 7.1.4 Programming Software in the United States.