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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 VSG SYSTEM, MODEL MX-1000
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 
S046 S048 
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