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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 NameVASOSEAL ES DEVICE
Classification Namedevice, hemostasis, vascular
Generic Namevascular hemostasis device
ApplicantDATASCOPE CORP.
PMA NumberP920004
Supplement NumberS008
Date Received11/13/1997
Decision Date12/11/1998
Product Code
MGB[ Registered Establishments with MGB ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to market a modified version of the vasoseal(r) vascular hemostasis device. The device, as modified, will be marketed under the trade name vasoseal(r) extra security (es) device and is indicated for reducing time to hemostasis at the femoral arterial puncture site and in reducing time to ambulation in patients who have undergone diagnostic angiography or interventional procedures.
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