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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameSTARCLOSE AND STARCLOSE SE VASCULAR CLOSURE SYSTEMS
Classification Namedevice, hemostasis, vascular
Generic Namevascular closure system
ApplicantABBOTT VASCULAR DEVICES
PMA NumberP050007
Supplement NumberS009
Date Received03/31/2008
Decision Date08/25/2008
Product Code
MGB[ Registered Establishments with MGB ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for modifications to the indications for use. The device, as modified, will be indicated for the following: the percutaneous closure of common femoral artery access sites while reducing times to hemostasis, ambulation, and dischargeability in patients who have undergone diagnostic endovascular catheterization procedures utilizing a 5f or 6f procedural sheath. The starclose vascular closure system is indicated for use to allow patients who have undergone diagnostic endovascular catheterization procedures to ambulate and be eligible for discharge as soon as possible after device placement. The starclose vascular closure system is indicated for the percutaneous closure of common femoral artery access sites while reducing times to hemostasis and ambulation, in patients who have undergone interventional endovascular catheterization procedures utilizing a 5f or 6f procedural sheath.
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