Saline breast implants
This article was originally published in The Gray Sheet
Executive Summary
FDA planning public meeting to discuss final call for premarket approval applications for saline breast implants. Topics that could be addressed at the session include timing of the final call in light of availability of safety and efficacy data to support PMAs for the devices. FDA issued a proposed call for the PMAs last year ("The Gray Sheet" Jan. 11, 1993, p. 2)