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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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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.
 
DeviceGELFOAM (ABSORBABLE GELATIN) STERILE SPONGE
Generic NameAgent, absorbable hemostatic, collagen based
Regulation Number878.4490
ApplicantPfizer, Inc.
235 E. 42nd St.
Ny, NY 10017
PMA NumberN18286
Supplement NumberS022
Date Received09/06/2011
Decision Date02/29/2012
Product Code LMF 
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
Approval Order Statement  
APPROVAL FOR A NEW CONVENIENCE KIT, GELFOAM PLUS ¿ POWDER TO BE COMPRISED OF GELFOAM POWDER, HUMAN THROMBIN, ONE SYRINGE THAT IS PRE-FILLED WITH 0.9% NAC1 SOLUTION, ONE EMPTY SYRINGE, A NEEDLELESS TRANSFER DEVICE AND AN APPLICATOR TIP.
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