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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 ABSORBABLE GELATIN SPONGE
Classification Nameagent, absorbable hemostatic, collagen based
Generic Nameabsorbable hemostatic agent
Regulation Number878.4490
ApplicantPFIZER, INC.
PMA NumberN18286
Supplement NumberS020
Date Received10/12/2010
Decision Date10/19/2010
Product Code
LMF[ Registered Establishments with LMF ]
Advisory Committee General & Plastic Surgery
Supplement Type Special Supplement
Supplement Reason labeling change - other
Expedited Review Granted? No
Combination Product No
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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