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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 STERILE POWDER
Classification Nameagent, absorbable hemostatic, collagen based
Generic Nameabsorbable hemostatic agent
Regulation Number878.4490
ApplicantTHE UPJOHN CO.
PMA NumberN18286
Supplement NumberS012
Date Received12/08/1999
Decision Date10/16/2000
Product Code
LMF[ Registered Establishments with LMF ]
Docket Number 00M-1616
Notice Date 11/15/2000
Advisory Committee General & Plastic Surgery
Supplement Typepanel track
Supplement Reason labeling change - indications
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Approval for the addition of bone hemostasis to the indications for use.
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