Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Devices@FDA
  • Print
  • Share
  • E-mail
-
 
Help | Download Files | More about PMA

New Search Back to Search Results
Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceAPLIGRAF
Generic NameDressing, wound and burn, interactive
ApplicantOrganogenesis, Inc.
150 Dan Rd.
Canton, MA 02021
PMA NumberP950032
Supplement NumberS044
Date Received05/15/2007
Decision Date07/13/2007
Conversion Date08/14/2013
Product Code MGR 
Advisory Committee General & Plastic Surgery
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR A NEW CELL STRAIN, HEP 040, FOR INTRODUCTION INTO PRODUCTION OF APLIGRAF. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME APLIGRAF AND IS INDICATED FOR THE TREATMENT OF PARTIAL AND FULL THICKNESS CHRONIC VENOUS ULCERS.
  We welcome your comments and feedback about Devices@FDA.
-
-