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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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66 supplements returned for P950032

New Search  Back to Search Results | Help
Device Name Company Date Approved Supplement Reason Other Information
apligraf (graftskin)

Organogenesis, Inc. May 22, 1998   Approval Order
Summary of Safety & Effectiveness
Labeling
apligraf (graftskin)

supplement #: S001
Organogenesis, Inc. Jul 09, 1998 process change - manufacturer/sterilizer/packager/supplier  
apligraf (graftskin)

supplement #: S002
Organogenesis, Inc. Jan 06, 1999 other  
apligraf (graftskin)

supplement #: S004
Organogenesis, Inc. Jan 06, 1999 postapproval study protocol  
apligraf (graftskin)

supplement #: S007
Organogenesis, Inc. Feb 01, 1999 change design/components/specifications/material  
apligraf (graftskin)

supplement #: S008
Organogenesis, Inc. Feb 23, 1999 postapproval study protocol  
apligraf tm

supplement #: S009
Organogenesis, Inc. Apr 19, 1999 process change - manufacturer/sterilizer/packager/supplier  
apligraf (graftskin)

supplement #: S010
Organogenesis, Inc. May 03, 2000 process change - manufacturer/sterilizer/packager/supplier  
apligraf (graftskin)

supplement #: S011
Organogenesis, Inc. Jun 24, 1999 change design/components/specifications/material  
apligraf(r) (graftskin)

supplement #: S014
Organogenesis, Inc. Oct 14, 1999 change design/components/specifications/material  
  We welcome your comments and feedback about Devices@FDA.
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