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 | 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. |
|
|