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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.
Classification Nameagent, absorbable hemostatic, collagen based
Generic Nameagent, absorbable hemostatic, collagen based
Regulation Number878.4490
235 east 42nd st.
new york, NY 10017
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 Typespecial (immediate track)
Supplement Reason labeling change - indications/instructions/shelf life/tradename
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. ¿.