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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 NumberS019
Date Received06/28/1999
Decision Date03/08/2000
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 6f angio-seal(tm) hemostatic puncture closure device. The device, as modified, will be marketed under the trade name 6f angio-seal(tm) hemostatic puncture closure device and is indicated for closing the femoral arterial puncture site in patients who have undergone diagnostic angiography procedures using a retrograde approach and a 6 french or smaller procedureal sheath. The angio-seal (tm) device reduces the times to hemostasis, ambulation and discharge in patients who have undergone diagnostic catheterization procedures without complicating clinical conditions (refer to precautions, special patient populations).