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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 PLUS HEMOSTASIS KIT
Generic NameAgent, absorbable hemostatic, collagen based
Regulation Number878.4490
ApplicantPfizer, Inc.
235 E. 42nd St.
Ny, NY 10017
PMA NumberN18286
Supplement NumberS018
Date Received02/26/2009
Decision Date06/10/2009
Product Code LMF 
Advisory Committee General & Plastic Surgery
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL OF CHANGES TO THE MANUFACTURING OF THE HUMAN THROMBIN COMPONENT OF THE GELFOAM PLUS HEMOSTASIS KIT THROUGH THE ADDITION OF A SOLVENT/ DETERGENT STEP (HUMAN THROMBIN VH S/D). THE THROMBIN IS TO BE MANUFACTURED AND SUPPLIED BY BAXTER HEALTHCARE CORPORATION.
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