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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: 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 
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