|
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. |