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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 NameSURGIFLO HEMOSTATIC MATRIX
Classification Nameagent, absorbable hemostatic, collagen based
Generic Nameabsorbable gelatin sponge, usp
Regulation Number878.4490
ApplicantETHICON, INC.
PMA NumberP990004
Supplement NumberS008
Date Received03/10/2005
Decision Date05/05/2005
Product Code
LMF[ Registered Establishments with LMF ]
Advisory Committee General & Plastic Surgery
Supplement Typereal-time process
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for marketing a pre-filled paste prepared from the powdered form of the absorbable gelatin sponge. The device, as modified, will be marketed under the trade name surgiflo hemostatic matrix 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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