|
Device | SALINE-FILLED BREAST IMPLANTS |
Generic Name | prosthesis, breast, inflatable, internal, saline |
Regulation Number | 878.3530 |
Applicant | Allergan 2525 dupont dr. irvine, CA 92612 |
PMA Number | P990074 |
Supplement Number | S013 |
Date Received | 08/09/2002 |
Decision Date | 08/23/2002 |
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 THE ADDITION OF 1) STYLES 68HP AND 68LP AND 2) CORRESPONDING PACKAGE LABELING. |