Premarket Approval (PMA)

Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.

• Device: SURGIFOAM ABSORBABLE GELATIN SPONGE, USP
• Generic Name: Agent, absorbable hemostatic, collagen based
• Regulation Number: 878.4490
• Applicant: Ferrosan Meidcal Devices A/S; Sydmarken 5; Soeborg 08876
• PMA Number: P990004
• Date Received: 01/22/1999
• Decision Date: 09/30/1999
• Product Code: LMF
• Docket Number: 99M-4776
• Advisory Committee: General & Plastic Surgery
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No
• Recalls: CDRH Recalls

Approval Order Statement  
Approval for the SURGIFOAM Absorbable Gelatin Sponge, U.S.P. This device is indicated for surgical procedures (except urologic, ophthalmic and neurologic) for hemostasis, when control of capillary, venous and arteriolar bleeding by pressure, ligature and other conventional procedures is ineffective or impractical.

• Approval Order: Approval Order
• Summary: Summary of Safety and Effectiveness
• Labeling: Labeling
• Supplements: S021 S010 S004 S007 S008 S005 S006 S014 S009 S003 S036 ; S001 S002 S017 S015 S011 S019 S018 S031 S030 S032 S034 S035 ; S042 S043 S038 S055 S056 S049 S050 S047 S048 S052 S053 S059 ; S060 S064 S067 S072 S075 S033 S065 S066 S061 S062 S063 S077 ; S078 S079 S076 S070 S071 S012 S013 S026 S027 S028 S022 S023 ; S025 S029 S016 S039 S040 S041 S024 S037 S081 S044 S045 S054 ; S058 S057 S051 S073 S074 S068 S069