|
Device | MENTOR SALINE -FILLED & SPECTRUM 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 | S021 |
Date Received | 04/02/2008 |
Decision Date | 03/31/2009 |
Product Code |
FWM |
Advisory Committee |
General & Plastic Surgery |
Supplement Type | normal 180 day track no user fee |
Supplement Reason | labeling change - indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR REVISED LABELING THAT REFLECTS 10-YEAR POST-APPROVAL STUDY DATA. |