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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
Generic NameAgent, absorbable hemostatic, collagen based
Regulation Number878.4490
ApplicantPfizer, Inc.
235 E. 42nd St.
Ny, NY 10017
PMA NumberN18286
Supplement NumberS028
Date Received04/20/2016
Decision Date03/01/2018
Product Code LMF 
Advisory Committee General & Plastic Surgery
Supplement TypeNormal 180 Day Track
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for an alternative packaging configuration for GELFOAM Sterile Powder under the trade name FLOSTAT NT as well as approval of the associated new manufacturing site for GELFOAM Sterile Powder manufacture (solely for FLOSTAT NT), kit assembly, secondary packaging, and sterilization at Vascular Solutions, Inc., 6464 Sycamore Court, Minneapolis, Minnesota.
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