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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 STERILE POWDER
Generic NameAgent, absorbable hemostatic, collagen based
Regulation Number878.4490
ApplicantPfizer, Inc.
235 E. 42nd St.
Ny, NY 10017
PMA NumberN18286
Supplement NumberS012
Date Received12/08/1999
Decision Date10/16/2000
Product Code LMF 
Docket Number 00M-1616
Notice Date 11/15/2000
Advisory Committee General & Plastic Surgery
Supplement TypePanel Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE ADDITION OF BONE HEMOSTASIS TO THE INDICATIONS FOR USE
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