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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
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 S024 S025 
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