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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.
 
Trade NameGELFOAM ABLSORBABLE GELATIN SPONGE AND GELFILM STERILE FILM
Classification Nameagent, absorbable hemostatic, collagen based
Generic Nameabsorbable hemostatic agent
Regulation Number878.4490
ApplicantTHE UPJOHN CO.
PMA NumberN18286
Supplement NumberS013
Date Received02/19/2002
Decision Date03/20/2002
Product Code
LMF[ Registered Establishments with LMF ]
Advisory Committee General & Plastic Surgery
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
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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