|
Device | NATRELLE SALINE BREAST IMPLANTS |
Generic Name | prosthesis, breast, inflatable, internal, saline |
Regulation Number | 878.3530 |
Applicant | Allergan 2525 dupont dr. irvine, CA 92612 |
PMA Number | P990074 |
Date Received | 11/16/1999 |
Decision Date | 05/10/2000 |
Product Code |
FWM |
Docket Number | 01M-0012 |
Notice Date | 01/18/2001 |
Advisory Committee |
General & Plastic Surgery |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR THE MCGHAN RTV SALINE-FILLED BREAST IMPLANT. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling
|
Supplements: |
S037 S034 S035 S038 S022 S023 S030 S011 S012 S013 S021 S016 S017 S025 S031 S032 S026 S028 S029 S003 S004 S005 S015 S018 S010 S014 S006 S007 S008 S009 S019 S020 S027 S024 S049 S050 S002 S033 S036 S039 S040 S041 S042 S043 S044 S045 S046 S047 S048 S001 |