|
Device | MENTOR SPECTRUM POST-OPERATIVELY ADJUSTABLE SALINE BREAST IMPLANTS |
Generic Name | prosthesis, breast, inflatable, internal, saline |
Regulation Number | 878.3530 |
Applicant |
MENTOR WORLDWIDE LLC |
33 technology drive |
irvine, CA 92618 |
|
PMA Number | P990075 |
Supplement Number | S019 |
Date Received | 01/24/2008 |
Decision Date | 07/28/2008 |
Product Code |
FWM
|
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 A NEW STANDARD AND MICRO INJECTION DOME (PORT) TEMPORARY USE ACCESSORY COMPONENT. |