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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 Nameabsorbable hemostatic agent
Regulation Number878.4490
PMA NumberN18286
Supplement NumberS010
Date Received09/16/1998
Decision Date10/14/1998
Product Code
LMF[ Registered Establishments with LMF ]
Advisory Committee General & Plastic Surgery
Supplement Type30-day notice
Supplement Reason process change: packaging
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
The 30-day notice request the addition of a new packaging machine (doyen) to package/seal the outer envelope (primary sterile barrier) of the gelforam(r) sterile sponge. The addition of the new packaging machine resulted in other hcange that included a new paper vendor and a change in the application of the adhesive pattern on the package. The label copy will be printe don line and no longer supplied by the paper vendor; and the smallest gelfoam(r) package size, 12-7 (3"x71/2") was changed to 4"x71/2" due to limitations of the doyen packaging machine. As a result of this packaging size change, the sterilization process was validated successfully. A uv decontamination procedure was also incorporated into the standard operating procedure for container closure integrity testing to minimize the risk of th false-positive results during sterility testing. The added packaging equipment will be used as the primary packaging line, while the ucrrent packaging equipment (circle) will be used as an alternate.