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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 ABLSORBABLE GELATIN SPONGE AND GELFILM STERILE FILM
Generic NameAgent, absorbable hemostatic, collagen based
Regulation Number878.4490
ApplicantPfizer, Inc.
235 E. 42nd St.
Ny, NY 10017
PMA NumberN18286
Supplement NumberS013
Date Received02/19/2002
Decision Date03/20/2002
Product Code LMF 
Advisory Committee General & Plastic Surgery
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
CHANGE TO THE BACTERIAL ENDOTOXIN TEST METHOD FOR GELFOAM ABSORBABLE GELATIN SPONGE AND GELFILM STERILE FILM IN ORDER TO COMPLY WITH THE RECENTLY HARMONIZED USP, EP AND JP COMPENDIA FOR BACTERIAL ENDOTOXIN ASSAY.
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