PMA N18286S010

Device: GELFOAM STERILE SPONGE
Applicant: Pfizer, Inc.
PMA number: N18286
Supplement: S010
Product code: LMF
Decision date: 1998-10-14
Classification: Agent, Absorbable Hemostatic, Collagen Based
Generic name: Agent, absorbable hemostatic, collagen based
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.

Current openFDA PMA Record#

Device: GELFOAM STERILE SPONGE
Applicant: Pfizer, Inc.
PMA number: N18286
Supplement: S010
Product code: LMF
Generic name: Agent, absorbable hemostatic, collagen based
Decision date: 1998-10-14
Decision code: OK30
Date received: 1998-09-16
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
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.