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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 VASCULAR CLOSURE DEVICE STS PLATFORM
Classification Namedevice, hemostasis, vascular
Generic Namevascular hemostasis device
ApplicantST. JUDE MEDICAL, INC.
PMA NumberP930038
Supplement NumberS031
Date Received03/20/2001
Decision Date08/28/2001
Product Code
MGB[ Registered Establishments with MGB ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason labeling change - trade name
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for adding the locking cap feature onto the delivery system of the angio-seal vascular closure device with self-tightening slipknot (sts). The device, as modified, will be marketed under the trade name angio-seal vascular closure device sts platform and is indicated for closing and reducing the time to hemostasis at the femoral arterial puncture site in patients who have undergone diagnostic angiographic procedures or interventional procedures using an 8 french or smaller procedural sheath for the 8f angio-seal device and a 6 french or smaller procedural sheath for the 6f angio-seal device.
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