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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.
Classification Nameagent, absorbable hemostatic, collagen based
Generic Nameagent, absorbable hemostatic, collagen based
Regulation Number878.4490
235 east 42nd st.
new york, NY 10017
PMA NumberN18286
Supplement NumberS025
Date Received04/17/2013
Decision Date06/03/2013
Product Code
LMF[ Registered Establishments with LMF ]
Advisory Committee General & Plastic Surgery
Supplement Typespecial (immediate track)
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for label changes to the instructions for use: for the following device iterations:1) gelfoam plus -original sponge ifu- needleless;2) gelfoam plus- powder ifu-needleless; 3) gelfoam plus - compressed sponge ifu needleless;4) gelfoam absorbable gelatin) sponge; 5) gelfoam (absorbable gelatin) dental sponge; 6) gelfoam (absorbable gelatin) compressed sponge; and 7) gelfoam (absorbable gelatin) powder. Add the precautionary statement:positioning of the patient resulting in negative peripheral venous pressure during a procedure has been reported to be a contributing factor resulting in life-threatening thromboembolic events. 2. For the following device iterations:1) gelfoam (absorbable gelatin) sponge; 2) gelfoam (absorbable gelatin) dental sponge; 3) gelfoam (absorbable gelatin) compressed sponge; and 4) gelfoam (absorbable gelatin) powder. Make minor changes to the existing precautionary statement: although the safety and efficacy of the combined use of gelfoam with other agents such as topical thrombin has not been evaluated in pharmacia- controlled clinical trials, if in the physicians judgment concurrent use of topical thrombin other agents is medically advisable, the product literature for that agent should be consulted for complete prescribing information.