Inamed Receives FDA Letter Requesting Additional PMA Information
Inamed has received a letter from the FDA regarding its Style 410 cohesive gel-filled breast implants premarket approval (PMA) application.
The letter outlines the additional information that Inamed must provide before the FDA can complete its review of Inamed's Style 410 PMA. According to the letter, submission of this requested information is necessary for the FDA to determine whether there is reasonable assurance that the Style 410 breast implants are safe and effective for their intended use.
The Style 410 is Inamed's next generation cohesive gel-filled breast implant. It is designed for memory and shape retention, and is marketed internationally as the Bio-Dimensional Cohesive Gel Matrix (Style 410).
The Style 410 breast implants are not part of Inamed's PMA application to be considered at the FDA's Medical Devices Advisory Committee meeting April 11-13, and the letter has no impact on the timing or substance of the matters to be considered at the April meeting.