AGA Medical Corporation Receives FDA and CE Mark Approvals for the AMPLATZER Vascular Plug II (FinanzNachrichten)
AGA Medical Corporation ("AGA") announced today that it has received U.S. Food and Drug Administration (FDA) and European CE Mark approvals for the AMPLATZER Vascular Plug II ("vascular plug II").

FDA's increased scrutiny puts pressure on drug makers (The Record)
TRENTON -- Under growing scrutiny since the blockbuster painkiller Vioxx was pulled from the market, the Food and Drug Administration in recent months has rejected a slew of experimental drugs or delayed their approval and required more data.