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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(TM)[1] HEMOSTATIC PUNCTURE CLOSURE DEVICE
Classification Namedevice, hemostasis, vascular
Generic Namefemoral artery puncture closing device
ApplicantQUINTON, INC.
PMA NumberP930038
Supplement NumberS005
Date Received04/16/1997
Decision Date05/01/1997
Product Code
MGB[ Registered Establishments with MGB ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason labeling change - indications
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Change to the indications for use for the angio-seal(tm) device. The angio-seal(tm) hemostatic puncture closure device is now 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 interventional procedures using an retrograde approach and an 8 french or smaller procedural sheath.
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