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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.
Classification Namedevice, hemostasis, vascular
Generic Namevascular hemostasis device
PMA NumberP930038
Supplement NumberS052
Date Received01/02/2008
Decision Date09/26/2008
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 use of the angio-seal vascular closure device in closure of femoral venous puncture sites and for the removal of the precaution statement relating to the use of the anticoagulant warfarin. The device, as modified, will be marketed under the trade name angio-seal vascular closure device and is indicated for use in closing and in reducing time to hemostasis at the femoral arterial and femoral venous puncture site in patients who have undergone diagnostic angiography or percutaneous transluminal coronary angioplasty (ptca) procedures using an 8 french or smaller procedural sheath.