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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceNATRELLE SALINE BREAST IMPLANTS
Generic NameProsthesis, breast, inflatable, internal, saline
Regulation Number878.3530
ApplicantAllergan
2525 DUPONT DR.
IRVINE, CA 92612
PMA NumberP990074
Date Received11/16/1999
Decision Date05/10/2000
Product Code FWM 
Docket Number 01M-0012
Notice Date 01/18/2001
Advisory Committee General & Plastic Surgery
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR THE MCGHAN RTV SALINE-FILLED BREAST IMPLANT.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Supplements:  S026 S023 S030 S028 S029 S016 S005 S006 S007 S003 S004 
S011 S012 S013 S017 S021 S015 S036 S038 S001 S002 S031 S032 
S024 S027 S025 S014 S008 S009 S010 S019 S020 S022 S018 S034 
S040 S037 S035 S033 S039 S041 S045 S050 S042 S044 S043 S046 
S047 S049 S048 
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