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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 NameSURGIFOAM ABSORBABLE GELATIN HEMORRHOIDECTOMY SPONGE
Generic Nameabsorbable gelatin sponge, usp
ApplicantETHICON, INC.
PMA NumberP990004
Supplement NumberS003
Date Received10/02/2000
Decision Date11/15/2000
Advisory Committee General & Plastic Surgery
Supplement Typereal-time process
Supplement Reason design change - minor
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a new configuration (hemorrhoidectomy sponge) of the absorbable gelatin sponge, usp as well as a new bubble wrap package, a change in the sterilization procedure involving the use of e-beam sterilization, and some minor changes to the package labeling. The device, as modified, will be marketed under the trade name surgifoam(r) absorba le gelatin sponge, usp, hemorrhoidectomy sponge and is indicated for surgical procedures (except urologic and ophthalmic) for hemostasis, when control of capillary, venous and arteriolar bleeding by pressure, ligature and other conventional procedures is ineffective or impractical.
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