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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 NumberS022
Date Received09/06/2011
Decision Date02/29/2012
Product Code
LMF[ Registered Establishments with LMF ]
Advisory Committee General & Plastic Surgery
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for a new convenience kit, gelfoam plus ¿ powder to be comprised of gelfoam powder, human thrombin, one syringe that is pre-filled with 0. 9% nac1 solution, one empty syringe, a needleless transfer device and an applicator tip.