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The FDA published draft guidance June 19 to assist device manufacturers in preparing for FDA’s review of their premarket approval (PMA) applications and for coordinating inspections of PMA supplements.
Medtronic has submitted the first premarket approval (PMA) module to the FDA for its Endeavor drug-eluting stent -- a move that brings the large devicemaker closer to entering the lucrative U.S. drug-coated stent market.
The FDA has moved one step closer to allowing Inamed to market and sell its silicone gel-filled breast implants after the agency’s General and Plastic Surgery Devices Advisory Panel recommended against approving the company’s premarket application for the implants in April 2005 by a 5-4 vote.
Pfizer and sanofi-aventis’ potential breakthrough diabetes drug Exubera has received the green light from an FDA advisory panel, which voted 7-2 Sept. 8 to recommend approval for the inhaled insulin powder.
The FDA announced Aug. 11 that submission rates for a premarket application (PMA) approval for medical devices for fiscal 2006 will increase roughly 8.5 percent over last year’s amount to $259,600.
An FDA advisory panel recommended approving Mentor’s new silicone-gel breast implants a day after rejecting rival company Inamed’s application, citing Mentor’s slightly lower rate of rupture and its longer-term studies.
The FDA has extended a pilot program for evaluating globally harmonized medical device premarket applications (premarket notifications, or 510(k)s, and premarket approval applications, or PMAs), accepting submissions in this format until July 2006.