Food and Drug Administration

General and Plastic Surgery Devices Panel Meeting

July 9, 2002

Briefing Information

Disclaimer

The statements contained in this document(s) are those of the product's sponsor, not FDA, and FDA does not necessarily agree with the sponsor's statements. FDA has not made a final determination about the safety or effectiveness of the product described in this document.

Update on the Conditions of Approval for the Approved Saline Filled Breast Implant Devices

June 5, 2020 memo on P990074 Inamed McGhan Saline-Filled Breast Implants Status of PMA Conditions of Approval, Samie Allen, ODE/DGRND/PRSB  doc  pdf

June 11, 2002 memo on P990075 Mentor Corporation, Saline-Filled and Spectrum Mammary Prostheses Status of PMA Conditions of Approval  doc  pdf