Medical Devices
Breast implant maker provides update on regulatory activities
Published in Health and Medicine Week, August 15th, 2005
The U.S. Food and Drug Administration (FDA) is currently reviewing the company's responsive gel implant and its cohesive gel implant (BioDimensional Style 410 Matrix) premarket approval applications (PMAs).
After consideration of the outcome of the April, 2005, FDA Advisory Panel meeting and in consultation with the FDA, the company modified its responsive gel PMA by separating data for eight round and the shaped Style 153 investigational devices. This PMA modification also included new 10-12 year...
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