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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 NameSURGIFORM ABSORBABLE GELATION SPONGE, USP
Generic Nameabsorbable gelatin sponge, usp
ApplicantETHICON, INC.
PMA NumberP990004
Supplement NumberS002
Date Received11/16/1999
Decision Date02/08/2000
Advisory Committee General & Plastic Surgery
Supplement Typereal-time process
Supplement Reason labeling change - indications
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
A change in the "indications for use" statement.
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