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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 SPONGE
Generic NameAgent, absorbable hemostatic, collagen based
Regulation Number878.4490
ApplicantPFIZER, INC.
235 EAST 42ND ST.
NEW YORK, NY 10017
PMA NumberN18286
Supplement NumberS020
Date Received10/12/2010
Decision Date10/19/2010
Product Code LMF 
Advisory Committee General & Plastic Surgery
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR AN UPDATE TO THE LABELING TO INCLUDE THE CONTRAINDICATION: ¿DO NOT USE GELFOAM ABSORBABLE GELATIN SPONGE IN PATIENTS WITH KNOWN ALLERGIES TO PORCINE COLLAGEN.¿
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