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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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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.
 
DeviceFLOSEAL MATRIX/FLOSEAL MATRIX HEMOSTATIC SEALANT/PROCEED HEMOSTATIC SEALANT
Generic NameAbsorbable collagen hemostatic agent with thrombin
Regulation Number878.4490
ApplicantBAXTER HEALTHCARE CORP.
32650 N WILSON RD
ROUND LAKE, IL 60073
PMA NumberP990009
Date Received02/22/1999
Decision Date12/08/1999
Product Code PMX 
Docket Number 00M-1229
Notice Date 12/08/1999
Advisory Committee General & Plastic Surgery
Expedited Review Granted? No
Combination ProductYes
RecallsCDRH Recalls
Approval Order Statement  
THE DEVICE IS INDICATED IN SURGICAL PROCEDURES (OTHER THAN IN NEUROSURGICAL, OPHTHALMIC, AND UROLOGICAL) AS AN ADJUNCT TO HEMOSTASIS WHEN CONTROL OF BLEEDING BY LIGATURE OR CONVENTIONAL PROCEDURES IS INEFFECTIVE OR IMPRACTICAL.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Supplements:  S001 S002 S003 S004 S005 S006 S007 S008 S009 S010 S011 
S012 S013 S014 S015 S016 S017 S018 S019 S020 S021 S022 S023 
S024 S025 S026 S027 S028 S029 S030 S031 S032 S033 S034 S035 
S036 S037 S038 S039 S040 S041 S042 S043 S044 S045 S046 S048 
S049 S050 S051 S052 S053 S054 S056 S057 S058 S059 S060 S061 
S062 S063 S064 S065 S067 S068 S069 S070 S071 S072 S073 
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