|
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. |