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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(r)(graftskin)

supplement #: S015
Organogenesis, Inc. Sep 28, 1999 process change - manufacturer/sterilizer/packager/supplier  
apligraf (graftskin)

supplement #: S016
Organogenesis, Inc. Jun 20, 2000 labeling change - indications/instructions/shelf life/tradename Approval Order
Summary of Safety & Effectiveness
Labeling
apligraf(r)(graftskin)

supplement #: S017
Organogenesis, Inc. Jun 16, 2000 labeling change - indications/instructions/shelf life/tradename  
apligraf(r)

supplement #: S018
Organogenesis, Inc. Aug 31, 2000 change design/components/specifications/material  
apligraf(r)(graftskin)

supplement #: S019
Organogenesis, Inc. Nov 19, 2001 labeling change - indications/instructions/shelf life/tradename  
apligraf (graftskin)

supplement #: S020
Organogenesis, Inc. Nov 07, 2001 change design/components/specifications/material  
apligraf(r)(graftskin)

supplement #: S021
Organogenesis, Inc. Dec 21, 2000 process change - manufacturer/sterilizer/packager/supplier  
apligraf(graftskin)

supplement #: S022
Organogenesis, Inc. Apr 26, 2001 process change - manufacturer/sterilizer/packager/supplier  
apligraf(r)

supplement #: S023
Organogenesis, Inc. May 09, 2001 change design/components/specifications/material  
apligraf/graftskin

supplement #: S024
Organogenesis, Inc. Jul 16, 2001 process change - manufacturer/sterilizer/packager/supplier  
  We welcome your comments and feedback about Devices@FDA.
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