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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 may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameNATRELLE SALINE BREAST IMPLANTS
Classification Nameprosthesis, breast, inflatable, internal, saline
Generic Namesilicone inflatable breast prosthesis
Regulation Number878.3530
ApplicantALLERGAN
PMA NumberP990074
Date Received11/16/1999
Decision Date05/10/2000
Product Code
FWM[ Registered Establishments with FWM ]
Docket Number 01M-0012
Notice Date 01/18/2001
Advisory Committee General & Plastic Surgery
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Recalls CDRH Recalls
Approval Order Statement 
Approval for the mcghan rtv saline-filled breast implant.
Approval Order Approval Order
Supplements: S001 S002 S003 S004 S005 S006 S007 S008 S009 
S010 S011 S012 S013 S014 S015 S016 S017 S018 
S019 S020 S021 S022 S023 S024 S025 S026 S027 
S028 S029 S030 S031 S032 
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