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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceGELFOAM
Classification Nameagent, absorbable hemostatic, collagen based
Generic Nameagent, absorbable hemostatic, collagen based
Regulation Number878.4490
Applicant
PFIZER, INC.
235 east 42nd st.
new york, NY 10017
PMA NumberN18286
Supplement NumberS023
Date Received10/13/2011
Decision Date03/06/2012
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 UPDATE ON THE MANUFACTURING SITE INFORMATION AND SYMBOLS ON THE LABELS.
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