|
Device | NATRELLE 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 | S020 |
Date Received | 09/04/2008 |
Decision Date | 10/24/2008 |
Product Code |
FWM
|
Advisory Committee |
General & Plastic Surgery |
Supplement Type | normal 180 day track no user fee |
Supplement Reason | location change - manufacturer/sterilizer/packager/supplier |
Expedited Review Granted? | No |
Combination Product |
No
|
Approval Order Statement
APPROVAL FOR A MANUFACTURING SITE LOCATED AT THE GLOBAL PARK FACILITY, LA AURORA DE HEREDIA, COSTA RICA, FOR THE SHELL DIPPING/FABRICATION PROCESS. |