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: MATRIX VASCULAR CLOSURE SYSTEM (VSG)
• Generic Name: Device, hemostasis, vascular
• Applicant: Cordis US Corporation; 14201 NW 60th Ave.; Miami Lakes, FL 33014
• PMA Number: P040044
• Date Received: 11/04/2004
• Decision Date: 08/17/2005
• Product Code: MGB
• Docket Number: 05M-0359
• Notice Date: 09/08/2005
• Advisory Committee: Cardiovascular
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No
• Recalls: CDRH Recalls

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
• Summary: Summary of Safety and Effectiveness
• Labeling: Labeling
• Supplements: S038 S036 S037 S046 S047 S066 S039 S007 S008 S009 S002 ; S003 S004 S073 S075 S074 S001 S005 S006 S019 S025 S026 S027 ; S028 S033 S010 S011 S029 S030 S031 S020 S021 S022 S023 S034 ; S012 S013 S014 S032 S024 S072 S077 S076 S078 S083 S092 S086 ; S095 S108 S110 S103 S104 S081 S079 S080 S082 S085 S099 S100 ; S101 S111 S040 S041 S064 S065 S068 S069 S057 S044 S058 S059 ; S060 S061 S062 S063 S070 S042 S048 S050 S043 S015 S016 S017 ; S045 S056 S084 S049 S113 S087 S088 S089 S051 S052 S053 S054 ; S055 S091 S093 S094 S090 S109 S102 S096 S097 S105 S106 S107