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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 NameANGIO-SEAL EVOLUTION VASCULAR CLOSURE DEVICE
Classification Namedevice, hemostasis, vascular
Generic Namevascular hemostasis device
ApplicantST. JUDE MEDICAL, INC.
PMA NumberP930038
Supplement NumberS054
Date Received01/22/2008
Decision Date03/18/2008
Product Code
MGB[ Registered Establishments with MGB ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason design change - minor
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for device modifications to the angio-seal vip vascular closure device including utilizing an automated collagen compaction mechanism for ease of use. The device, as modified, will be marketed under the trade name angio-seal evolution vascular closure device and is indicated for use in closing and in reducing time to hemostasis at the femoral arterial puncture site in patients who have undergone diagnostic angiography or percutaneous transluminal coronary angioplasty (ptca) procedures using an 8 french or smaller procedural sheath.
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