|
Device | HIGH PROFILE ROUND SALINE-FILLED BREAST IMPLANT, STYLE 3000 |
Applicant | MENTOR WORLDWIDE LLC 33 technology drive irvine, CA 92618 |
PMA Number | P990075 |
Supplement Number | S003 |
Date Received | 05/14/2001 |
Decision Date | 06/18/2001 |
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 THE HIGH PROFILE ROUND SALINE-FILLED BREAST IMPLANT, STYLE 3000. |