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
• 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 S001 S002 S006 S022 S024 S009 S012 S013 S004 S016 ; S005 S014 S010 S029 S031 S003 S026 S027 S028 S023 S025 S017 ; S015 S007 S008 S019 S011 S018 S030 S032 S037 S042 S043 S036 ; S052 S053 S055 S056 S057 S050 S060 S038 S034 S035 S039 S040 ; S041 S033 S058 S059 S054 S044 S045 S047 S048 S051 S049 S061 ; S062 S063 S065