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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 (TM)
Classification Namedevice, hemostasis, vascular
Generic Namevascular hemostasis device
ApplicantDATASCOPE CORP.
PMA NumberP920004
Supplement NumberS006
Date Received02/25/1997
Decision Date04/15/1997
Product Code
MGB[ Registered Establishments with MGB ]
Docket Number N
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason labeling change - indications
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a change to the indications for use to include sue of vasoseal(r) following stent implantation. The vasoseal(r) vascular hemostasis device is now indicated for use in reducing tiem to hemostasis at the femoral arterial puncture site and in reducing time to ambulation in patients who have undergone diagnostic angiography, balloon angioplasty or stent procedures using an 8 french or smaller procedural sheath and using a retrograde approach. The vasoseal(r) vhd is also indicated for use in reducing time to hemostasis in balloon angioplasty and stent patients when immediate shealth removal is desired. However, early ambulation in these patients has not been demonstrated.
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