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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.
Classification Namedevice, hemostasis, vascular
PMA NumberP960043
Date Received11/26/1996
Decision Date04/30/1997
Product Code
MGB[ Registered Establishments with MGB ]
Docket Number 97M-0274
Notice Date 07/08/1997
Advisory Committee Cardiovascular
Expedited Review Granted? Yes
Combination Product No
Approval Order Statement 
Approval for the prostar(r) percutaneous vascular surgical (pvs) system. The prostar(r) pvs system consists of the prostar(r) pvs device (9 and 11 french sizes) and the following accessories: a prostar(r) pre-dilator (9 and 11 french sizes), a perclose(r) knot pusher, and prostar(r) transition guidewire, and a perclose(r) arterial tamper. The prostar(r) pvs system is indicated for the percutaneous delivery of sutures for closing the common femoral artery access site anc reducing the time to hemostasis and ambulation (time-to-standing) of patients who have undergone interventional procedures using 8 to 11 french sheaths.
Supplements: S001 S002 S003 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 S035 S036 S037 S038 
S039 S040 S041 S042 S043 S044 S045 S046 S047 
S048 S049 S052 S053 S054 S055 S056 S057 S058 
S059 S060 S061 S062 S063 S064 S065 S066 S067 
S068 S069 S070 S071 S072 S073 S074 S075 S076 
S077 S078 S079 S080 S082 S083 S084 S085 S086 
S087 S088 S089 S090