FDA Requests Inamed’s Breast-Implant Data
From Bloomberg News
Inamed Corp. of Santa Barbara, a maker of medical devices seeking to sell the first silicone-gel breast implant in the U.S. in 11 years, said it received a “not approvable” letter from the Food and Drug Administration.
The letter outlines what information Inamed must provide to the FDA on silicone-gel breast implants, the company said.