Fw: McGhan & Mentor Summary of Safety & Effectiveness

[Guest guest]

http://www.fda.gov/cdrh/newpg.html

There are 6 very important FDA documents relating to new Approval Orders

for McGhan and Mentor saline implants. They are at this website, but

available only as PDF ...

Go here to the website and go down to January 18th.

They talk about " no closed capsulotomies " (please someone post this to

www.implantinfo.com discussion board ... the PS's there are still doing

them) ...

Thanks much to Jan for finding this for us ...

Mentor Corporation Saline-Filled and Spectrum® Mammary Prostheses

P990075

Issued 05-10-2000

Part 1 - Approval Order

Part 2 - Summary of Safety and Effectiveness

Part 3 - Labeling