Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
|
Device | MENTOR SALINE-FILLED MAMMARY PROSTHESES |
Applicant | MENTOR WORLDWIDE LLC 33 technology drive irvine, CA 92618 |
PMA Number | P990075 |
Supplement Number | S002 |
Date Received | 10/23/2000 |
Decision Date | 12/22/2000 |
Advisory Committee |
General & Plastic Surgery |
Supplement Type | normal 180 day track |
Supplement Reason | change design/components/specifications/material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR AN INCREASED SHELL THICKNESS OF THE CONTOUR TALL PROFILE STYLES 5000, 5000PT, 6000, AND 6000PT. |
|
|