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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameGELFOAM PLUS HEMOSTASIS KIT
Classification Nameagent, absorbable hemostatic, collagen based
Generic Nameabsorbable hemostatic agent
Regulation Number878.4490
ApplicantPFIZER, INC.
PMA NumberN18286
Supplement NumberS018
Date Received02/26/2009
Decision Date06/10/2009
Product Code
LMF[ Registered Establishments with LMF ]
Advisory Committee General & Plastic Surgery
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
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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