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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 (ABSORABLE GELATIN) POWDER, USP
Classification Nameagent, absorbable hemostatic, collagen based
Generic Nameabsorbable hemostatic agent
Regulation Number878.4490
ApplicantPFIZER, INC.
PMA NumberN18286
Supplement NumberS024
Date Received12/03/2012
Decision Date01/07/2013
Product Code
LMF[ Registered Establishments with LMF ]
Advisory Committee General & Plastic Surgery
Supplement Typereal-time process
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a minor change in labeling instructions to include mixing gelfoam powder with diluents of saline for injection or thrombin. No other change included in this approval order. The device along with the modified labeling will be marketed under the trade name gelfoam absorbable gelatin powder: is intended as a hemostatic device for surgical procedures when control of capillary, venous and arteriolar bleeding by pressure, ligature, and other conventional procedures is either ineffective or impractical. Although not necessary, gelfoam sterile powder can be used either with or without thrombin to obtain hemostasis.
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