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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
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 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 - manufacturer/sterilizer/packager/supplier
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.