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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 (ABSORBABLE GELATIN) STERILE SPONGE
Classification Nameagent, absorbable hemostatic, collagen based
Generic Nameabsorbable hemostatic agent
Regulation Number878.4490
ApplicantPFIZER, INC.
PMA NumberN18286
Supplement NumberS021
Date Received05/24/2011
Decision Date07/09/2011
Product Code
LMF[ Registered Establishments with LMF ]
Advisory Committee General & Plastic Surgery
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for a change in some of the components contained in the gelfoam plus kit as well as the introduction of an alternative gelfoam plus kit gelfoam plus compressed. The component changes will substitute prefilled saline syringes and a needleless transfer device for the standard saline vials and needle-syringe. The components have been cleared/ approved previously. The purpose of the gelfoam plus kit is to provide the convenience of co-packaged collagen sponge, saline diluent and human thrombin to a physician during surgery.
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