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. |
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Device | GELFOAM STERILE SPONGE |
Generic Name | Agent, absorbable hemostatic, collagen based |
Regulation Number | 878.4490 |
Applicant | PFIZER, INC. 235 EAST 42ND ST. NEW YORK, NY 10017 |
PMA Number | N18286 |
Supplement Number | S010 |
Date Received | 09/16/1998 |
Decision Date | 10/14/1998 |
Product Code |
LMF |
Advisory Committee |
General & Plastic Surgery |
Supplement Type | 30-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. |
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