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U.S. Department of Health and Human Services

Devices@FDA
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Note: if a medical device has supplements, the device description and instructions may have
changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
 
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55 supplements returned for P020056

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Device Name Company Date Approved Supplement Reason Other Information
natrelle silicone-filled breast implants

Allergan Nov 17, 2006   Approval Order
Summary of Safety & Effectiveness
Labeling &  Labeling 2
inamed silicone-filled breast implants

supplement #: S001
Allergan Aug 22, 2007 express gmp supplement  
natrelle silicone-filled breast implants

supplement #: S002
Allergan May 02, 2007 change design/components/specifications/material  
natrelle silicone-filled breast implant

supplement #: S003
Allergan May 17, 2007 labeling change - indications/instructions/shelf life/tradename  
natrelle silicone-filled breast implants

supplement #: S004
Allergan Mar 20, 2008 location change - manufacturer/sterilizer/packager/supplier  
natrelle silicone-filled breast implants

supplement #: S005
Allergan Apr 11, 2008 process change - manufacturer/sterilizer/packager/supplier  
natrelle silicone-filled breast implants

supplement #: S006
Allergan Aug 06, 2008 postapproval study protocol - osb  
allergan silicone-filled breast implants

supplement #: S007
Allergan Sep 12, 2008 process change - manufacturer/sterilizer/packager/supplier  
natrelle silicone-filled breast implants

supplement #: S008
Allergan Nov 04, 2008 postapproval study protocol - osb  
natrelle silicone-filled breast implants

supplement #: S009
Allergan Apr 22, 2009 labeling change - pas  
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