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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 NumberS029
Date Received01/08/2001
Decision Date07/26/2001
Product Code
MGB[ Registered Establishments with MGB ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the self-tightening slipknot (sts) modification to the angio-seal vascular closure device. The device, as modified, will be marketed under the trade name angio-seal vascular closure device: self-tightening slipknot (sts) and is indicated for closing and reducing the time to hemostasis at the femoral arterial puncture site in patients who have undertone a diagnostic angiographic procedure or an interventional procedure using an 8french procedural sheath for the 8f angio-seal sts device and a 6f or smaller procedural sheath for the 6f angio-seal sts device.