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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 may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameMATRIX VASCULAR CLOSURE SYSTEM (VSG)
Classification Namedevice, hemostasis, vascular
ApplicantACCESS CLOSURE, INC.
PMA NumberP040044
Date Received11/04/2004
Decision Date08/17/2005
Product Code
MGB[ Registered Establishments with MGB ]
Docket Number 05M-0359
Notice Date 09/08/2005
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Approval for the matrix vsg system, model mx-100. The device is indicated for use to seal femoral arterial access sites while reducing times to hemostasis and ambulation in patients who have undergone diagnostic or interventional endovascular procedures utilizing a 5f, 6f, or 7f procedural sheath.
Approval Order Approval Order
Supplements: S001 S002 S003 S004 S005 S006 S007 S008 S009 
S010 S011 S012 S013 S014 S015 S016 S017 S019 
S020 S021 S022 S023 S024 S025 S026 S027 S028 
S029 S030 S031 S032 S033 S034 S036 S037 S038 
S039 S040 S041 S042 S043 S044 S045 S046 S047 
S048 S049 S050 S051 S052 S053 S054 S055 S056 
S057 
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