The U.S. Food and Drug Administration (FDA) issued an approvable letter to Mentor Corporation for their application for silicone gel-filled breast implants.
Federal law and regulations prohibit the government from discussing the specific contents of the letter. However, an approvable letter is one of several intermediate steps in the FDA review process of new products.
Previously at their April 2005 meeting, the General and Plastic Surgery Devices Advisory Committee voted 7-2 that Mentor?s application was ‘approvable with conditions’. This letter does not mean that the device is approved for marketing in the United States at this time.
Mentor said the letter spells out certain conditions the company must meet to receive FDA approval to market the implants in the United States.