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FDA asks Inamed for more breast implant information

This article was originally published in Clinica

Executive Summary

The US FDA has asked Inamed for more information regarding its premarket approval (PMA) application for the its next generation cohesive gel-filled breast implants, Style 410. In a letter to the Santa Barbara, California company, the agency said that it needed the information to determine whether there is reasonable assurance that the implants are safe and effective for their intended use.

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